- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01130272
Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea
September 30, 2019 updated by: Furiex Pharmaceuticals, Inc
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
807
Phase
- Phase 2
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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Alabama
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Anniston, Alabama, United States, 36207
- Furiex research site
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Birmingham, Alabama, United States, 35216
- Furiex research site
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Birmingham, Alabama, United States, 35235
- Furiex research site
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Dothan, Alabama, United States, 36305
- Furiex research site
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Huntsville, Alabama, United States, 35802
- Furiex research site
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Huntsville, Alabama, United States, 35801
- Furiex research site
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Mobile, Alabama, United States, 36693
- Furiex research site
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Montgomery, Alabama, United States, 36109
- Furiex research site
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Pell City, Alabama, United States, 35128
- Furiex research site
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Arizona
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Chandler, Arizona, United States, 85224
- Furiex research site
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Glendale, Arizona, United States, 85308
- Furiex research site
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Mesa, Arizona, United States, 85203
- Furiex research site
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Phoenix, Arizona, United States, 85018
- Furiex research site
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Phoenix, Arizona, United States, 85020
- Furiex research site
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Phoenix, Arizona, United States, 85050
- Furiex research site
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Tempe, Arizona, United States, 85282
- Furiex research site
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Tempe, Arizona, United States, 85283
- Furiex research site
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Tucson, Arizona, United States, 85704
- Furiex research site
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Tucson, Arizona, United States, 85710
- 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, 72211
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Searcy, Arkansas, United States, 72143
- Furiex research site
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Sherwood, Arkansas, United States, 72120
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California
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Aliso Viejo, California, United States, 92656
- Furiex research site
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Anaheim, California, United States, 92801
- Furiex research site
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Azusa, California, United States, 91702
- Furiex research site
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Burbank, California, United States, 91505
- Furiex research site
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Carlsbad, California, United States, 92008
- Furiex research site
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Encinitas, California, United States, 92024
- Furiex research site
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Garden Grove, California, United States, 92843
- Furiex research site
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Garden Grove, California, United States, 92840
- Furiex research site
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Inglewood, California, United States, 90301
- Furiex research site
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Laguna Hills, California, United States, 92653
- 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, 90015
- Furiex research site
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Los Angeles, California, United States, 90045
- Furiex research site
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Murietta, California, United States, 92562
- Furiex research site
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Oakland, California, United States, 94609
- Furiex research site
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Orange, California, United States, 92869
- Furiex research site
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Sacramento, California, United States, 95825
- Furiex research site
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San Carlos, California, United States, 94070
- Furiex research site
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San Diego, California, United States, 92103-6204
- Furiex research site
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San Diego, California, United States, 92120
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Colorado
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Colorado Springs, Colorado, United States, 80904
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Colorado Springs, Colorado, United States, 80907
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Colorado Springs, Colorado, United States, 80920
- Furiex research site
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Colorado Springs, Colorado, United States, 80922
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Denver, Colorado, United States, 80222
- Furiex research site
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Denver, Colorado, United States, 80239
- Furiex research site
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Lakewood, Colorado, United States, 80215
- Furiex research site
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Littleton, Colorado, United States, 80120
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Thornton, Colorado, United States, 80229
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Connecticut
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Bristol, Connecticut, United States, 06010
- Furiex research site
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Waterbury, Connecticut, United States, 06708
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Florida
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Aventura, Florida, United States, 33916
- Furiex research site
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Boca Raton, Florida, United States, 33428
- Furiex research site
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Boca Raton, Florida, United States, 33432
- Furiex research site
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Bradenton, Florida, United States, 34208
- Furiex research site
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Brandon, Florida, United States, 33511
- Furiex research site
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Chipley, Florida, United States, 32428
- Furiex research site
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DeLand, Florida, United States, 32720
- Furiex research site
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Delray Beach, Florida, United States, 33484
- Furiex research site
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Doral, Florida, United States, 33172
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Fort Lauderdale, Florida, United States, 33306
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Hialeah, Florida, United States, 33016
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Hialeah, Florida, United States, 33013
- Furiex research site
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Inverness, Florida, United States, 34452
- Furiex research site
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Jacksonville, Florida, United States, 32209
- Furiex research site
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Jacksonville, Florida, United States, 32256
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Jupiter, Florida, United States, 33458
- Furiex research site
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Kissimmee, Florida, United States, 34741
- Furiex research site
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Largo, Florida, United States, 33777
- Furiex research site
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Lauderdale Lakes, Florida, United States, 33319
- Furiex research site
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Melbourne, Florida, United States, 32935
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33135
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Miami, Florida, United States, 33155
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Naples, Florida, United States, 34102
- Furiex research site
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Naples, Florida, United States, 34109
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New Port Richey, Florida, United States, 34652
- Furiex research site
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New Port Richey, Florida, United States, 34655
- Furiex research site
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New Smyrna Beach, Florida, United States, 32168
- Furiex research site
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Orlando, Florida, United States, 32837
- Furiex research site
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Plantation, Florida, United States, 33317
- Furiex research site
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Port Orange, Florida, United States, 32129
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Saint Petersburg, Florida, United States, 33709
- Furiex research site
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South Miami, Florida, United States, 33143
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Tampa, Florida, United States, 33606
- Furiex research site
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Tampa, Florida, United States, 33613
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Georgia
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Atlanta, Georgia, United States, 30338
- Furiex research site
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Atlanta, Georgia, United States, 30312
- Furiex research site
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Columbus, Georgia, United States, 31904
- Furiex research site
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Duluth, Georgia, United States, 30096
- 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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Newnan, Georgia, United States, 30263
- Furiex research site
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Rome, Georgia, United States, 30165
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Sandy Springs, Georgia, United States, 30328
- Furiex research site
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Savannah, Georgia, United States, 31406
- Furiex research site
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Idaho
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Boise, Idaho, United States, 83702
- Furiex research site
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Boise, Idaho, United States, 83704
- Furiex research site
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Idaho Falls, Idaho, United States, 83404
- Furiex research site
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Meridian, Idaho, United States, 83642
- Furiex research site
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Nampa, Idaho, United States, 83686
- Furiex research site
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Illinois
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Champaign, Illinois, United States, 61820
- Furiex research site
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Chicago, Illinois, United States, 60634
- Furiex research site
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Morton, Illinois, United States, 61550
- Furiex research site
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Indiana
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Anderson, Indiana, United States, 46016
- Furiex research site
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Bloomington, Indiana, United States, 47403
- Furiex research site
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Evansville, Indiana, United States, 47714
- Furiex research site
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Indianapolis, Indiana, United States, 46205
- Furiex research site
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Indianapolis, Indiana, United States, 46237
- Furiex research site
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Indianapolis, Indiana, United States, 46250
- Furiex research site
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Kansas
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Lenexa, Kansas, United States, 66215
- Furiex research site
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Mission, Kansas, United States, 66202
- Furiex research site
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Overland Park, Kansas, United States, 66202
- Furiex research site
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Overland Park, Kansas, United States, 66215
- Furiex research site
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Topeka, Kansas, United States, 66606
- Furiex research site
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Wichita, Kansas, United States, 67203
- Furiex research site
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Kentucky
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Bowling Green, Kentucky, United States, 42101
- Furiex research site
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Lexington, Kentucky, United States, 40504
- Furiex research site
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Louisville, Kentucky, United States, 40202
- Furiex research site
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Louisiana
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Metairie, Louisiana, United States, 70006
- Furiex research site
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Monroe, Louisiana, United States, 71201
- Furiex research site
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Opelousas, Louisiana, United States, 70570
- Furiex research site
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Shreveport, Louisiana, United States, 71101
- Furiex research site
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Shreveport, Louisiana, United States, 71103
- Furiex research site
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Maryland
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Annapolis, Maryland, United States, 21401
- Furiex research site
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Chevy Chase, Maryland, United States, 20815
- Furiex research site
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Hollywood, Maryland, United States, 20636
- Furiex research site
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Laurel, Maryland, United States, 20707
- Furiex research site
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Lutherville, Maryland, United States, 21093
- Furiex research site
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Prince Frederick, Maryland, United States, 20678
- Furiex research site
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Rockville, Maryland, United States, 20850
- Furiex research site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Furiex research site
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Boston, Massachusetts, United States, 02135
- Furiex research site
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Boston, Massachusetts, United States, 02215
- Furiex research site
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Brockton, Massachusetts, United States, 02301
- Furiex research site
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Hyannis, Massachusetts, United States, 02601
- Furiex research site
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Springfield, Massachusetts, United States, 01105
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Michigan
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Chesterfield, Michigan, United States, 48047
- Furiex research site
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Interlochen, Michigan, United States, 49643
- Furiex research site
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Kalamazoo, Michigan, United States, 49009
- Furiex research site
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Novi, Michigan, United States, 48377
- Furiex research site
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Troy, Michigan, United States, 48098
- Furiex research site
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Minnesota
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Chaska, Minnesota, United States, 55318
- Furiex research site
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Mississippi
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Jackson, Mississippi, United States, 39202
- Furiex research site
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Tupelo, Mississippi, United States, 38801
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Missouri
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Mexico, Missouri, United States, 65265
- Furiex research site
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Saint Louis, Missouri, United States, 63141
- Furiex research site
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Saint Peters, Missouri, United States, 63376
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Montana
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Billings, Montana, United States, 59102
- Furiex research site
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Bozeman, Montana, United States, 59718
- Furiex research site
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Nebraska
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Bellevue, Nebraska, United States, 68005
- Furiex research site
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Omaha, Nebraska, United States, 68114
- Furiex research site
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Omaha, Nebraska, United States, 68144
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Nevada
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Henderson, Nevada, United States, 89052
- Furiex research site
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Las Vegas, Nevada, United States, 89106
- Furiex research site
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Las Vegas, Nevada, United States, 89183
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New Jersey
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Atco, New Jersey, United States, 08044
- Furiex research site
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Blackwood, New Jersey, United States, 08012
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Elizabeth, New Jersey, United States, 07202
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Marlton, New Jersey, United States, 08053
- Furiex research site
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Morristown, New Jersey, United States, 07960
- Furiex research site
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South Bound Brook, New Jersey, United States, 08880
- Furiex research site
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Vineland, New Jersey, United States, 08360
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New Mexico
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Albuquerque, New Mexico, United States, 87102
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Albuquerque, New Mexico, United States, 87108
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New York
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Binghamton, New York, United States, 13903
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Brooklyn, New York, United States, 11230
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Brooklyn, New York, United States, 11214
- Furiex research site
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Great Neck, New York, United States, 11023
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Great Neck, New York, United States, 11021
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Mineola, New York, United States, 11501
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New York, New York, United States, 10016
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North Carolina
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Boone, North Carolina, United States, 28607
- Furiex research site
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Chapel Hill, North Carolina, United States, 27599
- Furiex research site
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Charlotte, North Carolina, United States, 28209
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Charlotte, North Carolina, United States, 28277
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Fayetteville, North Carolina, United States, 28304
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Greensboro, North Carolina, United States, 27403
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Greensboro, North Carolina, United States, 27401
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Greenville, North Carolina, United States, 27834
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Harrisburg, North Carolina, United States, 28075
- Furiex research site
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Hickory, North Carolina, United States, 28602
- Furiex research site
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Hickory, North Carolina, United States, 28601
- Furiex research site
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High Point, North Carolina, United States, 27262
- Furiex research site
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Jacksonville, North Carolina, United States, 28546
- Furiex research site
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New Bern, North Carolina, United States, 28562
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Raleigh, North Carolina, United States, 27609
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Raleigh, North Carolina, United States, 27612
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Wilmington, North Carolina, United States, 28401
- Furiex research site
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Winston-Salem, North Carolina, United States, 27103
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Winston-Salem, North Carolina, United States, 27103-3914
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North Dakota
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Fargo, North Dakota, United States, 58103
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Fargo, North Dakota, United States, 58104
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Ohio
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Akron, Ohio, United States, 44302
- Furiex research site
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Beachwood, Ohio, United States, 44122
- Furiex research site
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Beavercreek, Ohio, United States, 45432
- Furiex research site
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Cincinnati, Ohio, United States, 45229
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Cleveland, Ohio, United States, 44122
- Furiex research site
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Columbus, Ohio, United States, 43215
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Columbus, Ohio, United States, 43214
- Furiex research site
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Dayton, Ohio, United States, 45432
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Franklin, Ohio, United States, 45005
- Furiex research site
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Mentor, Ohio, United States, 44060
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Miamisburg, Ohio, United States, 45342-3705
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Springfield, Ohio, United States, 45504
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Wadsworth, Ohio, United States, 44281
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Oklahoma
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Norman, Oklahoma, United States, 73069
- Furiex research site
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Norman, Oklahoma, United States, 73071
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Oklahoma City, Oklahoma, United States, 73104
- Furiex research site
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Oklahoma City, Oklahoma, United States, 73112
- Furiex research site
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Yukon, Oklahoma, United States, 73099
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Pennsylvania
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Dingmans Ferry, Pennsylvania, United States, 18328
- Furiex research site
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Hermitage, Pennsylvania, United States, 16148
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Jenkintown, Pennsylvania, United States, 19046
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Lancaster, Pennsylvania, United States, 17604
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Lansdale, Pennsylvania, United States, 19446
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Newton, Pennsylvania, United States, 18940
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Sayre, Pennsylvania, United States, 18840
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Uniontown, Pennsylvania, United States, 15401
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Washington, Pennsylvania, United States, 15301
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Rhode Island
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Cumberland, Rhode Island, United States, 02864
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East Providence, Rhode Island, United States, 02914
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Warwick, Rhode Island, United States, 02886
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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
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Columbia, South Carolina, United States, 29203
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Greer, South Carolina, United States, 29651
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Mount Pleasant, South Carolina, United States, 29464
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South Dakota
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Rapid City, South Dakota, United States, 57702
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Tennessee
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Bristol, Tennessee, United States, 37620
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Chattanooga, Tennessee, United States, 37421
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Chattanooga, Tennessee, United States, 37404
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Germantown, Tennessee, United States, 38138
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Jackson, Tennessee, United States, 38301
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Johnson City, Tennessee, United States, 37604
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Kingsport, Tennessee, United States, 37660
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Nashville, Tennessee, United States, 37203
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Nashville, Tennessee, United States, 37205
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Texas
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Austin, Texas, United States, 78705
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Bedford, Texas, United States, 76022
- Furiex research site
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Colleyville, Texas, United States, 76034
- Furiex research site
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El Paso, Texas, United States, 79902
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Fort Worth, Texas, United States, 76107
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Fort Worth, Texas, United States, 76108
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Grand Prairie, Texas, United States, 75052
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Grapevine, Texas, United States, 76051
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77005
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Houston, Texas, United States, 77022
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77034
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Houston, Texas, United States, 77081
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Houston, Texas, United States, 77090
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Houston, Texas, United States, 77505
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Hurst, Texas, United States, 76054
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Irving, Texas, United States, 75061
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Lake Jackson, Texas, United States, 77566
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Marshall, Texas, United States, 75670
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North Richland Hills, Texas, United States, 76180
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Odessa, Texas, United States, 79761
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Plano, Texas, United States, 75074
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San Antonio, Texas, United States, 78209
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78258
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San Antonio, Texas, United States, 78212
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San Antonio, Texas, United States, 78215
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Sugar Land, Texas, United States, 77478
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Sugar Land, Texas, United States, 77479
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Webster, Texas, United States, 77598
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Utah
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Logan, Utah, United States, 84341
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Ogden, Utah, United States, 84405
- Furiex research site
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Salt Lake City, Utah, United States, 84109
- Furiex research site
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Salt Lake City, Utah, United States, 84121
- Furiex research site
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South Jordan, Utah, United States, 84095
- Furiex research site
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West Jordan, Utah, United States, 84088
- Furiex research site
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West Valley City, Utah, United States, 84120
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Virginia
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Alexandria, Virginia, United States, 22304
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Chesapeake, Virginia, United States, 23320
- Furiex research site
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Christiansburg, Virginia, United States, 24073
- Furiex research site
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Danville, Virginia, United States, 24541
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Fairfax, Virginia, United States, 22031
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Virginia Beach, Virginia, United States, 23455
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Washington
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Mill Creek, Washington, United States, 98012-6316
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Wisconsin
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Madison, Wisconsin, United States, 53715
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Milwaukee, Wisconsin, United States, 53226
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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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
- Female patients must be:
- postmenopausal, defined as amenorrhea 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.
Key Exclusion Criteria:
- Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
- Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
- Patient has a history of diverticulitis within 6 months prior to Prescreening
- Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eluxadoline 5 mg
Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
|
Tablets, orally, twice daily.
Other Names:
|
Experimental: Eluxadoline 25 mg
Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .
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Tablets, orally, twice daily.
Other Names:
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Experimental: Eluxadoline 100 mg
Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
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Tablets, orally, twice daily.
Other Names:
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Experimental: Eluxadoline 200 mg
Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
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Tablets, orally, twice daily.
Other Names:
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Placebo Comparator: Placebo
Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
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Matching placebo oral tablets twice daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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 at Week 4
Time Frame: Baseline (Week prior to Randomization) to Week 4
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Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week.
Abdominal pain was assessed on an 11-point scale where: 0=no pain to 10=worst pain imaginable.
Stool consistency was assessed using the BSS 7-point scale where: 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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Baseline (Week prior to Randomization) to Week 4
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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 at Week 12
Time Frame: Baseline (Week prior to Randomization) to Week 12
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Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week.
The participant recorded their abdominal pain in a daily diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable.
The participant recorded stool consistency in a daily diary using the BSS 7-point scale where: 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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Baseline (Week prior to Randomization) to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Weekly Pain Scores
Time Frame: Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12
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The participant recorded their worst daily pain score in a diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable.
The daily scores over the previous week were averaged.
A negative change from Baseline indicates improvement.
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Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12
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Change From Baseline in Weekly BSS Scores
Time Frame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
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The patient recorded stool consistency in a daily diary using the BSS 7-point scale where: 1=hard stool to 7=watery diarrhea.
The daily scores over the previous week were averaged.
A negative change from Baseline indicates improvement.
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Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
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Change From Baseline in the Number of Daily Bowel Movements
Time Frame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
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Participants recorded the number of bowel movements in a daily diary at the same time each day.
The number of daily bowel movements over the previous week were averaged.
A negative change from Baseline indicates improvement.
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Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
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Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time
Time Frame: Baseline (Week Prior to Randomization) to Weeks 1-12
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Responders were participants that met both of the following criteria on the same week for at least 50% of time on study: 1) average of daily pain scores over the past week improved by ≥30% compared with baseline average in pain score, 2) ≥50% reduction in the number of days over the past week with a BSS score ≥5 compared with Baseline.
Participants must also have had at least 5/7 days diary entry to be considered a responder for that week.
Abdominal pain was assessed on an 11-point scale where a score of 0=no pain to 10=worst pain imaginable.
Stool consistency was assessed using the BSS 7-point scale where: 1=separate hard lumps to 7=watery with no solid pieces.
Response rates (percentage of participants) are based on model estimates from the logistic regression.
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Baseline (Week Prior to Randomization) to Weeks 1-12
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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.
- Andrae DA, Covington PS, Patrick DL. Item-level assessment of the irritable bowel syndrome quality of life questionnaire in patients with diarrheal irritable bowel syndrome. Clin Ther. 2014 May;36(5):663-79. doi: 10.1016/j.clinthera.2014.04.009. Epub 2014 May 9.
- Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. doi: 10.1053/j.gastro.2013.04.006. Epub 2013 Apr 9.
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)
April 28, 2010
Primary Completion (Actual)
July 14, 2011
Study Completion (Actual)
July 14, 2011
Study Registration Dates
First Submitted
May 24, 2010
First Submitted That Met QC Criteria
May 24, 2010
First Posted (Estimate)
May 25, 2010
Study Record Updates
Last Update Posted (Actual)
October 22, 2019
Last Update Submitted That Met QC Criteria
September 30, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27018966IBS2001
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.
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Clinical Trials on Eluxadoline
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Furiex Pharmaceuticals, IncCompletedIrritable Bowel SyndromeUnited States, Canada, United Kingdom
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