- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01553747
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
July 27, 2018 updated by: Furiex Pharmaceuticals, Inc
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1146
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 3G8
- Furiex research site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1E 2E2
- Furiex research site
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Ontario
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Burlington, Ontario, Canada, L7M 4Y1
- Furiex research site
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Hawkesbury, Ontario, Canada, K6A 1A1
- Furiex research site
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London, Ontario, Canada, N5W 6A2
- Furiex research site
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Newmarket, Ontario, Canada, L3Y 5G8
- Furiex research site
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Sarnia, Ontario, Canada, N7T 4X3
- Furiex research site
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Sudbury, Ontario, Canada, P3E 1H5
- Furiex research site
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Toronto, Ontario, Canada, M6H 3M1
- Furiex research site
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Vaughan, Ontario, Canada, L4L 4Y7
- Furiex research site
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San Juan, Puerto Rico, 00926-2832
- Furiex research site
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Birmingham, United Kingdom, B15 2TH
- Furiex research site
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County Durham, United Kingdom, DL14 6AD
- Furiex research site
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Coventry, United Kingdom, CV2 2DX
- Furiex research site
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Durham, United Kingdom, DH1 5TW
- Furiex research site
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Edinburgh, United Kingdom, EH4 2XH
- Furiex research site
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Manchester, United Kingdom, M23 9LT
- Furiex research site
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Sheffield, United Kingdom, S10 2JF
- Furiex research site
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Wigan, United Kingdom, WN1 2NN
- Furiex research site
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Kent
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Chestfield, Kent, United Kingdom, CT5 3QS
- Furiex research site
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Lancashire
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Blackpool, Lancashire, United Kingdom, FY4 3AD
- Furiex research site
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Alabama
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Birmingham, Alabama, United States, 35209
- Furiex research site
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Birmingham, Alabama, United States, 35242
- Furiex research site
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Decatur, Alabama, United States, 35603
- Furiex research site
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Huntsville, Alabama, United States, 35801
- Furiex research site
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Mobile, Alabama, United States, 36608
- Furiex research site
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Montgomery, Alabama, United States, 36109
- Furiex research site
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Sheffield, Alabama, United States, 35660
- Furiex research site
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Tuscaloosa, Alabama, United States, 35401
- Furiex research site
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Arizona
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Glendale, Arizona, United States, 85306
- Furiex research site
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Glendale, Arizona, United States, 85308
- Furiex research site
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Mesa, Arizona, United States, 85206
- Furiex research site
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Phoenix, Arizona, United States, 85023
- Furiex research site
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Phoenix, Arizona, United States, 85032
- Furiex research site
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Tucson, Arizona, United States, 85712
- Furiex research site
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Tucson, Arizona, United States, 85704
- Furiex research site
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- Furiex research site
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Little Rock, Arkansas, United States, 72205
- Furiex research site
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Sherwood, Arkansas, United States, 72120
- Furiex research site
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California
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Anaheim, California, United States, 92801
- Furiex research site
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Chula Vista, California, United States, 91910
- Furiex research site
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Encinitas, California, United States, 92024
- Furiex research site
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Garden Grove, California, United States, 92840
- Furiex research site
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Huntington Beach, California, United States, 92647
- Furiex research site
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Irvine, California, United States, 92604
- Furiex research site
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La Mesa, California, United States, 91942
- Furiex research site
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La Mirada, California, United States, 90638
- Furiex research site
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Laguna Hills, California, United States, 92653
- Furiex research site
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Lakewood, California, United States, 90805
- Furiex research site
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Lincoln, California, United States, 95648
- Furiex research site
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Loma Linda, California, United States, 92354
- Furiex research site
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Lomita, California, United States, 90717
- Furiex research site
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Long Beach, California, United States, 90806
- Furiex research site
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Los Angeles, California, United States, 90045
- Furiex research site
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Newport Beach, California, United States, 92663
- Furiex research site
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North Hollywood, California, United States, 91606
- Furiex research site
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Northridge, California, United States, 91325
- Furiex research site
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Pasadena, California, United States, 91105
- Furiex research site
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Sacramento, California, United States, 95817
- Furiex research site
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San Diego, California, United States, 92103
- Furiex research site
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San Diego, California, United States, 92105
- Furiex research site
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Santa Ana, California, United States, 92701
- Furiex research site
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Ventura, California, United States, 93003
- Furiex research site
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Walnut Creek, California, United States, 94598
- Furiex research site
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Colorado
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Denver, Colorado, United States, 80211
- Furiex research site
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Denver, Colorado, United States, 80246
- Furiex research site
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Florida
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Boca Raton, Florida, United States, 33428
- Furiex research site
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Boynton Beach, Florida, United States, 33426
- Furiex research site
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Bradenton, Florida, United States, 34208
- Furiex research site
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Brooksville, Florida, United States, 34601
- Furiex research site
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Clearwater, Florida, United States, 33759
- Furiex research site
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Cooper City, Florida, United States, 33024
- Furiex research site
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Coral Springs, Florida, United States, 33065
- Furiex research site
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Eustis, Florida, United States, 32726
- Furiex research site
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Fort Lauderdale, Florida, United States, 33308
- Furiex research site
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Hallandale Beach, Florida, United States, 33009
- Furiex research site
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Hialeah, Florida, United States, 33016
- Furiex research site
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Jacksonville, Florida, United States, 32205
- Furiex research site
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Jupiter, Florida, United States, 33458
- Furiex research site
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Lauderdale Lakes, Florida, United States, 33319
- Furiex research site
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Melbourne, Florida, United States, 32901
- Furiex research site
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Miami, Florida, United States, 33015
- Furiex research site
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Miami, Florida, United States, 33125
- Furiex research site
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Miami, Florida, United States, 33126
- Furiex research site
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Miami, Florida, United States, 33133
- Furiex research site
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Miami, Florida, United States, 33135
- Furiex research site
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Miami, Florida, United States, 33144
- Furiex research site
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Miami, Florida, United States, 33155
- Furiex research site
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Miami, Florida, United States, 33183
- Furiex research site
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Miramar, Florida, United States, 33025
- Furiex research site
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New Port Richey, Florida, United States, 34652
- Furiex research site
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Orlando, Florida, United States, 32806
- Furiex research site
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Plant City, Florida, United States, 33563
- Furiex research site
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Port Orange, Florida, United States, 32127
- Furiex research site
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Saint Petersburg, Florida, United States, 33709
- Furiex research site
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Saint Petersburg, Florida, United States, 33705
- Furiex research site
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South Miami, Florida, United States, 33143
- Furiex research site
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Tampa, Florida, United States, 33607
- Furiex research site
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Wellington, Florida, United States, 33414
- Furiex research site
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Winter Haven, Florida, United States, 33880
- Furiex research site
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Winter Park, Florida, United States, 32792
- Furiex research site
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Georgia
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Alpharetta, Georgia, United States, 30005
- Furiex research site
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Athens, Georgia, United States, 30606
- Furiex research site
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Atlanta, Georgia, United States, 30338
- Furiex research site
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Atlanta, Georgia, United States, 30308
- Furiex research site
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Dunwoody, Georgia, United States, 30338
- Furiex research site
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Lawrenceville, Georgia, United States, 30046
- Furiex research site
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Macon, Georgia, United States, 31201
- Furiex research site
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Marietta, Georgia, United States, 30066
- Furiex research site
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Norcross, Georgia, United States, 30092
- Furiex research site
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Savannah, Georgia, United States, 31404
- Furiex research site
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Stockbridge, Georgia, United States, 30281
- Furiex research site
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Idaho
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Boise, Idaho, United States, 83704
- Furiex research site
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Eagle, Idaho, United States, 83616
- Furiex research site
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Idaho Falls, Idaho, United States, 83404
- Furiex research site
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Illinois
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Addison, Illinois, United States, 60101
- Furiex research site
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Chicago, Illinois, United States, 60612
- Furiex research site
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Chicago, Illinois, United States, 60622
- Furiex research site
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Evergreen Park, Illinois, United States, 60805
- Furiex research site
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Hammond, Illinois, United States, 46324
- Furiex research site
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Springfield, Illinois, United States, 62703
- Furiex research site
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Indiana
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Brownsburg, Indiana, United States, 46112
- Furiex research site
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Evansville, Indiana, United States, 47714
- Furiex research site
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Granger, Indiana, United States, 46530
- Furiex research site
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Iowa
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Clive, Iowa, United States, 50325
- Furiex research site
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Kansas
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Pratt, Kansas, United States, 67124
- Furiex research site
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Shawnee Mission, Kansas, United States, 66218
- Furiex research site
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Topeka, Kansas, United States, 66606
- Furiex research site
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Kentucky
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Lexington, Kentucky, United States, 40504
- Furiex research site
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Lexington, Kentucky, United States, 40503
- Furiex research site
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Owensboro, Kentucky, United States, 42303
- Furiex research site
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Paducah, Kentucky, United States, 42003
- Furiex research site
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Louisiana
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Lake Charles, Louisiana, United States, 70601
- Furiex research site
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Monroe, Louisiana, United States, 71201
- Furiex research site
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Maryland
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Hagerstown, Maryland, United States, 21742
- Furiex research site
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Hollywood, Maryland, United States, 20636
- Furiex research site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Furiex research site
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Boston, Massachusetts, United States, 02131
- Furiex research site
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Brockton, Massachusetts, United States, 02302
- Furiex research site
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Watertown, Massachusetts, United States, 02472
- Furiex research site
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Michigan
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Ann Arbor, Michigan, United States, 48106
- Furiex research site
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Bay City, Michigan, United States, 48706
- Furiex research site
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Cadillac, Michigan, United States, 49601
- Furiex research site
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Grand Rapids, Michigan, United States, 49506
- Furiex research site
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Kalamazoo, Michigan, United States, 49009
- Furiex research site
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Troy, Michigan, United States, 48098
- Furiex research site
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Ypsilanti, Michigan, United States, 48197
- Furiex research site
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Minnesota
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Plymouth, Minnesota, United States, 55446
- Furiex research site
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Mississippi
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Biloxi, Mississippi, United States, 39531
- Furiex research site
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Missouri
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Hazelwood, Missouri, United States, 63042
- Furiex research site
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Saint Louis, Missouri, United States, 63128
- Furiex research site
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Saint Louis, Missouri, United States, 63141
- Furiex research site
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Saint Louis, Missouri, United States, 63122
- Furiex research site
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Saint Peters, Missouri, United States, 63376
- Furiex research site
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Montana
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Billings, Montana, United States, 59101
- Furiex research site
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Nebraska
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Bellevue, Nebraska, United States, 68005
- Furiex research site
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Elkhorn, Nebraska, United States, 68022
- Furiex research site
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Lincoln, Nebraska, United States, 68510
- Furiex research site
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Omaha, Nebraska, United States, 68134
- Furiex research site
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Omaha, Nebraska, United States, 68144
- Furiex research site
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Nevada
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Las Vegas, Nevada, United States, 89123
- Furiex research site
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Reno, Nevada, United States, 89511
- Furiex research site
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Furiex research site
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New Jersey
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Blackwood, New Jersey, United States, 08012
- Furiex research site
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Edison, New Jersey, United States, 08817
- Furiex research site
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Elizabeth, New Jersey, United States, 07201
- Furiex research site
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Marlton, New Jersey, United States, 08053
- Furiex research site
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Furiex research site
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Albuquerque, New Mexico, United States, 87108
- Furiex research site
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Albuquerque, New Mexico, United States, 87109
- Furiex research site
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New York
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Flushing, New York, United States, 11367
- Furiex research site
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Hollis, New York, United States, 11423
- Furiex research site
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Mineola, New York, United States, 11501
- Furiex research site
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New York, New York, United States, 10016
- Furiex research site
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Furiex research site
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Dunn, North Carolina, United States, 28334
- Furiex research site
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Greensboro, North Carolina, United States, 27403
- Furiex research site
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Huntersville, North Carolina, United States, 28078
- Furiex research site
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Kinston, North Carolina, United States, 28501
- Furiex research site
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Wilmington, North Carolina, United States, 28403
- Furiex research site
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Winston-Salem, North Carolina, United States, 27103
- Furiex research site
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Winston-Salem, North Carolina, United States, 27106
- Furiex research site
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Ohio
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Akron, Ohio, United States, 44302
- Furiex research site
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Beavercreek, Ohio, United States, 45431
- Furiex research site
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Cincinnati, Ohio, United States, 45224
- Furiex research site
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Cincinnati, Ohio, United States, 45242
- Furiex research site
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Cincinnati, Ohio, United States, 45245
- Furiex research site
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Cincinnati, Ohio, United States, 45267
- Furiex research site
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Cleveland, Ohio, United States, 44122
- Furiex research site
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Columbus, Ohio, United States, 43214
- Furiex research site
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Columbus, Ohio, United States, 43212
- Furiex research site
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Columbus, Ohio, United States, 43235
- Furiex research site
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Dayton, Ohio, United States, 45432
- Furiex research site
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Dayton, Ohio, United States, 45439
- Furiex research site
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Groveport, Ohio, United States, 43125
- Furiex research site
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Kettering, Ohio, United States, 45429
- Furiex research site
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Lima, Ohio, United States, 45806
- Furiex research site
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Tiffin, Ohio, United States, 44883
- Furiex research site
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Toledo, Ohio, United States, 43615
- Furiex research site
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Oklahoma
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Norman, Oklahoma, United States, 73071
- Furiex research site
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Oklahoma City, Oklahoma, United States, 73112
- Furiex research site
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Oklahoma City, Oklahoma, United States, 73102
- Furiex research site
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Oregon
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Portland, Oregon, United States, 97210
- Furiex research site
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Salem, Oregon, United States, 97301
- Furiex research site
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Pennsylvania
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Carnegie, Pennsylvania, United States, 15106
- Furiex research site
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Philadelphia, Pennsylvania, United States, 19107
- Furiex research site
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Pittsburgh, Pennsylvania, United States, 15243
- Furiex research site
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Pittsburgh, Pennsylvania, United States, 15206
- Furiex research site
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Scottdale, Pennsylvania, United States, 15683
- Furiex research site
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Uniontown, Pennsylvania, United States, 15401
- Furiex research site
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Rhode Island
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Warwick, Rhode Island, United States, 02888
- Furiex research site
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South Carolina
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Anderson, South Carolina, United States, 29621
- Furiex research site
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Columbia, South Carolina, United States, 29201
- Furiex research site
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Columbia, South Carolina, United States, 29203
- Furiex research site
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Columbia, South Carolina, United States, 29204
- Furiex research site
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Easley, South Carolina, United States, 29640
- Furiex research site
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Mount Pleasant, South Carolina, United States, 29464
- Furiex research site
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North Myrtle Beach, South Carolina, United States, 29582
- Furiex research site
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South Dakota
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Rapid City, South Dakota, United States, 57702
- Furiex research site
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Tennessee
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Athens, Tennessee, United States, 37303
- Furiex research site
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Chattanooga, Tennessee, United States, 37404
- Furiex research site
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Columbia, Tennessee, United States, 38401
- Furiex research site
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Jackson, Tennessee, United States, 38305
- Furiex research site
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Knoxville, Tennessee, United States, 37919
- Furiex research site
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Smyrna, Tennessee, United States, 37167
- Furiex research site
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Texas
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Austin, Texas, United States, 78745
- Furiex research site
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Beaumont, Texas, United States, 77701
- Furiex research site
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Bedford, Texas, United States, 76021
- Furiex research site
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Corsicana, Texas, United States, 75110
- Furiex research site
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Dallas, Texas, United States, 75218
- Furiex research site
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Dallas, Texas, United States, 75225
- Furiex research site
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Fort Worth, Texas, United States, 76133
- Furiex research site
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Frisco, Texas, United States, 75035
- Furiex research site
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Houston, Texas, United States, 77008
- Furiex research site
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Houston, Texas, United States, 77043
- Furiex research site
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Houston, Texas, United States, 77062
- Furiex research site
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Humble, Texas, United States, 77338
- Furiex research site
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Hurst, Texas, United States, 76054
- Furiex research site
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San Antonio, Texas, United States, 78229
- Furiex research site
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San Antonio, Texas, United States, 78258
- Furiex research site
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San Antonio, Texas, United States, 78215
- Furiex research site
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Utah
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Bountiful, Utah, United States, 84010
- Furiex research site
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Salt Lake City, Utah, United States, 84124
- Furiex research site
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West Valley City, Utah, United States, 84120
- Furiex research site
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Vermont
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Burlington, Vermont, United States, 05401
- Furiex research site
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Virginia
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Alexandria, Virginia, United States, 22304
- Furiex research site
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Christiansburg, Virginia, United States, 24073
- Furiex research site
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Midlothian, Virginia, United States, 23114
- Furiex research site
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Norfolk, Virginia, United States, 23502
- Furiex research site
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Richmond, Virginia, United States, 23233
- Furiex research site
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Richmond, Virginia, United States, 23235
- Furiex research site
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West Virginia
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Charleston, West Virginia, United States, 25304
- Furiex research site
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Wisconsin
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Monroe, Wisconsin, United States, 53566
- Furiex research site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant is 18 to 80 years old
- Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
2. Participant has had a colonoscopy performed:
- Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)
Since the onset (if applicable) of any of the following alarm features for participants of any age
- Participant has documented weight loss within the past 6 months
- Participant has nocturnal symptoms
- Participant has a familial history of first-degree relatives with colon cancer
Participant has blood mixed with their stool (excluding blood from hemorrhoids).
3. Female participants must be:
- Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
- Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
- Abstinent, or
- If sexually active, be practicing an effective method of birth control.
Exclusion Criteria:
- Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
- Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
- Participant has a history of diverticulitis within 3 months prior to Prescreening.
- Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
Participant has any of the following surgical history:
- Cholecystectomy with any history of post cholecystectomy biliary tract pain
- Any abdominal surgery within the 3 months prior to Prescreening
- Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)
Other protocol-specific eligibility criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Eluxadoline 75 mg
Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.
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Oral tablets twice daily
Other Names:
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Experimental: Eluxadoline 100 mg
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.
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Oral tablets twice daily
Other Names:
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Placebo Comparator: Placebo
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.
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Oral tablets twice daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
Time Frame: Up to 12 weeks
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Composite responders were defined as participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest.
A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization).
2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain.
Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
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Up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Time Frame: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
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Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval.
A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.
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12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
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Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale
Time Frame: 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)
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Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary.
IBS-AR responders were defined as participants with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval.
A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder.
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12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)
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Change From Baseline in Daily Abdominal Discomfort Scores
Time Frame: Baseline, Weeks 4, 12 and 26
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Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort.
A negative change from Baseline indicates the discomfort decreased.
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Baseline, Weeks 4, 12 and 26
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Change From Baseline in Daily Abdominal Bloating Scores
Time Frame: Baseline, Weeks 4, 12 and 26
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Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating.
A negative change from Baseline indicates the bloating decreased.
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Baseline, Weeks 4, 12 and 26
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Number of Bowel Movements Per Day
Time Frame: Weeks 4, 12 and 26
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Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.
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Weeks 4, 12 and 26
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Number of Bowel Incontinence Episodes
Time Frame: Weeks 4, 12 and 26
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Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.
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Weeks 4, 12 and 26
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Number of Bowel Incontinence Free Days
Time Frame: Weeks 4, 12 and 26
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An incontinence free day was one where the participant reports zero incontinence episodes.
The number of incontinence free days for a participant was assessed each week based on the number of reported days.
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Weeks 4, 12 and 26
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Number of Urgency Episodes Per Day
Time Frame: Weeks 4, 12 and 26
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Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.
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Weeks 4, 12 and 26
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Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
Time Frame: Up to 26 weeks
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Composite responders were defined as participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest.
A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization).
2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain.
Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
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Up to 26 weeks
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Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Time Frame: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
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Stool consistency responders: Participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval.
BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces.
A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder.
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12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
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Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
Time Frame: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
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IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 [none] or 1 [mild]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval.
IBS-d Global Symptom Scale was a 5-point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms.
A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.
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12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
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Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
Time Frame: Weeks 4, 8, 12, 18, 26 and 30 (End of Treatment [EOT])
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IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit.
The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses.
The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation.
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Weeks 4, 8, 12, 18, 26 and 30 (End of Treatment [EOT])
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Change From Baseline in IBS-QoL Total Scores
Time Frame: Baseline, Weeks 4, 8, 12, 18, 26 and 30/EOT
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The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses.
The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation.
A positive change from Baseline indicates that quality of life improved.
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Baseline, Weeks 4, 8, 12, 18, 26 and 30/EOT
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1021-1029.e6. doi: 10.1016/j.cgh.2017.01.026. Epub 2017 Feb 3.
- Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2012
Primary Completion (Actual)
January 9, 2014
Study Completion (Actual)
January 9, 2014
Study Registration Dates
First Submitted
March 8, 2012
First Submitted That Met QC Criteria
March 13, 2012
First Posted (Estimate)
March 14, 2012
Study Record Updates
Last Update Posted (Actual)
July 30, 2018
Last Update Submitted That Met QC Criteria
July 27, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27018966IBS3002
- 2012-001601-24 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
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Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
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Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
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University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
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University of ViennaCompleted
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Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
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Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
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GlaxoSmithKlineCompletedIrritable Bowel Syndrome (IBS) | Irritable ColonUnited States
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Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
Clinical Trials on Eluxadoline
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AllerganEnrolling by invitationIrritable Bowel SyndromeUnited States
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Temple UniversityAllerganWithdrawnDiabetes | Diarrhea | Diabetic DiarrheaUnited States
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University of North Carolina, Chapel HillAllerganWithdrawnDiarrhea | Fecal Incontinence | Urge Incontinence | Anal Incontinence | Accidental Bowel Leakage
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AllerganCompletedIrritable Bowel Syndrome With DiarrheaUnited States
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AllerganCompletedIrritable Bowel Syndrome With DiarrheaUnited States, Canada
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Furiex Pharmaceuticals, IncCompletedIrritable Bowel SyndromeUnited States, Canada, United Kingdom
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AbbVieRecruitingIrritable Bowel SyndromeUnited States, Canada, Poland, United Kingdom, Hungary, Bulgaria, Netherlands
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Furiex Pharmaceuticals, IncCompletedIrritable Bowel SyndromeUnited States
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University of North Carolina, Chapel HillNational Institute of Environmental Health Sciences (NIEHS)CompletedAllergic AsthmaUnited States
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John H. Stroger HospitalEli Lilly and CompanyCompleted