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

Irritable Bowel Syndrome

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

United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Furiex research site
  - Birmingham, Alabama, United States, 35216
    - Furiex research site
  - Birmingham, Alabama, United States, 35235
    - Furiex research site
  - Dothan, Alabama, United States, 36305
    - Furiex research site
  - Huntsville, Alabama, United States, 35802
    - Furiex research site
  - Huntsville, Alabama, United States, 35801
    - Furiex research site
  - Mobile, Alabama, United States, 36693
    - Furiex research site
  - Montgomery, Alabama, United States, 36109
    - Furiex research site
  - Pell City, Alabama, United States, 35128
    - Furiex research site
- Arizona
  - Chandler, Arizona, United States, 85224
    - Furiex research site
  - Glendale, Arizona, United States, 85308
    - Furiex research site
  - Mesa, Arizona, United States, 85203
    - Furiex research site
  - Phoenix, Arizona, United States, 85018
    - Furiex research site
  - Phoenix, Arizona, United States, 85020
    - Furiex research site
  - Phoenix, Arizona, United States, 85050
    - Furiex research site
  - Tempe, Arizona, United States, 85282
    - Furiex research site
  - Tempe, Arizona, United States, 85283
    - Furiex research site
  - Tucson, Arizona, United States, 85704
    - Furiex research site
  - Tucson, Arizona, United States, 85710
    - Furiex research site
- Arkansas
  - Jonesboro, Arkansas, United States, 72401
    - Furiex research site
  - Little Rock, Arkansas, United States, 72211
    - Furiex research site
  - Searcy, Arkansas, United States, 72143
    - Furiex research site
  - Sherwood, Arkansas, United States, 72120
    - Furiex research site
- California
  - Aliso Viejo, California, United States, 92656
    - Furiex research site
  - Anaheim, California, United States, 92801
    - Furiex research site
  - Azusa, California, United States, 91702
    - Furiex research site
  - Burbank, California, United States, 91505
    - Furiex research site
  - Carlsbad, California, United States, 92008
    - Furiex research site
  - Encinitas, California, United States, 92024
    - Furiex research site
  - Garden Grove, California, United States, 92843
    - Furiex research site
  - Garden Grove, California, United States, 92840
    - Furiex research site
  - Inglewood, California, United States, 90301
    - Furiex research site
  - Laguna Hills, California, United States, 92653
    - Furiex research site
  - Long Beach, California, United States, 90806
    - Furiex research site
  - Los Angeles, California, United States, 90015
    - Furiex research site
  - Los Angeles, California, United States, 90045
    - Furiex research site
  - Murietta, California, United States, 92562
    - Furiex research site
  - Oakland, California, United States, 94609
    - Furiex research site
  - Orange, California, United States, 92869
    - Furiex research site
  - Sacramento, California, United States, 95825
    - Furiex research site
  - San Carlos, California, United States, 94070
    - Furiex research site
  - San Diego, California, United States, 92103-6204
    - Furiex research site
  - San Diego, California, United States, 92120
    - Furiex research site
- Colorado
  - Colorado Springs, Colorado, United States, 80904
    - Furiex research site
  - Colorado Springs, Colorado, United States, 80907
    - Furiex research site
  - Colorado Springs, Colorado, United States, 80920
    - Furiex research site
  - Colorado Springs, Colorado, United States, 80922
    - Furiex research site
  - Denver, Colorado, United States, 80222
    - Furiex research site
  - Denver, Colorado, United States, 80239
    - Furiex research site
  - Lakewood, Colorado, United States, 80215
    - Furiex research site
  - Littleton, Colorado, United States, 80120
    - Furiex research site
  - Thornton, Colorado, United States, 80229
    - Furiex research site
- Connecticut
  - Bristol, Connecticut, United States, 06010
    - Furiex research site
  - Waterbury, Connecticut, United States, 06708
    - Furiex research site
- Florida
  - Aventura, Florida, United States, 33916
    - Furiex research site
  - Boca Raton, Florida, United States, 33428
    - Furiex research site
  - Boca Raton, Florida, United States, 33432
    - Furiex research site
  - Bradenton, Florida, United States, 34208
    - Furiex research site
  - Brandon, Florida, United States, 33511
    - Furiex research site
  - Chipley, Florida, United States, 32428
    - Furiex research site
  - DeLand, Florida, United States, 32720
    - Furiex research site
  - Delray Beach, Florida, United States, 33484
    - Furiex research site
  - Doral, Florida, United States, 33172
    - Furiex research site
  - Fort Lauderdale, Florida, United States, 33306
    - Furiex research site
  - Hialeah, Florida, United States, 33016
    - Furiex research site
  - Hialeah, Florida, United States, 33013
    - Furiex research site
  - Inverness, Florida, United States, 34452
    - Furiex research site
  - Jacksonville, Florida, United States, 32209
    - Furiex research site
  - Jacksonville, Florida, United States, 32256
    - Furiex research site
  - Jupiter, Florida, United States, 33458
    - Furiex research site
  - Kissimmee, Florida, United States, 34741
    - Furiex research site
  - Largo, Florida, United States, 33777
    - Furiex research site
  - Lauderdale Lakes, Florida, United States, 33319
    - Furiex research site
  - Melbourne, Florida, United States, 32935
    - Furiex research site
  - Miami, Florida, United States, 33126
    - Furiex research site
  - Miami, Florida, United States, 33135
    - Furiex research site
  - Miami, Florida, United States, 33155
    - Furiex research site
  - Naples, Florida, United States, 34102
    - Furiex research site
  - Naples, Florida, United States, 34109
    - Furiex research site
  - New Port Richey, Florida, United States, 34652
    - Furiex research site
  - New Port Richey, Florida, United States, 34655
    - Furiex research site
  - New Smyrna Beach, Florida, United States, 32168
    - Furiex research site
  - Orlando, Florida, United States, 32837
    - Furiex research site
  - Plantation, Florida, United States, 33317
    - Furiex research site
  - Port Orange, Florida, United States, 32129
    - Furiex research site
  - Saint Petersburg, Florida, United States, 33709
    - Furiex research site
  - South Miami, Florida, United States, 33143
    - Furiex research site
  - Tampa, Florida, United States, 33606
    - Furiex research site
  - Tampa, Florida, United States, 33613
    - Furiex research site
- Georgia
  - Atlanta, Georgia, United States, 30338
    - Furiex research site
  - Atlanta, Georgia, United States, 30312
    - Furiex research site
  - Columbus, Georgia, United States, 31904
    - Furiex research site
  - Duluth, Georgia, United States, 30096
    - Furiex research site
  - Macon, Georgia, United States, 31201
    - Furiex research site
  - Marietta, Georgia, United States, 30066
    - Furiex research site
  - Newnan, Georgia, United States, 30263
    - Furiex research site
  - Rome, Georgia, United States, 30165
    - Furiex research site
  - Sandy Springs, Georgia, United States, 30328
    - Furiex research site
  - Savannah, Georgia, United States, 31406
    - Furiex research site
- Idaho
  - Boise, Idaho, United States, 83702
    - Furiex research site
  - Boise, Idaho, United States, 83704
    - Furiex research site
  - Idaho Falls, Idaho, United States, 83404
    - Furiex research site
  - Meridian, Idaho, United States, 83642
    - Furiex research site
  - Nampa, Idaho, United States, 83686
    - Furiex research site
- Illinois
  - Champaign, Illinois, United States, 61820
    - Furiex research site
  - Chicago, Illinois, United States, 60634
    - Furiex research site
  - Morton, Illinois, United States, 61550
    - Furiex research site
- Indiana
  - Anderson, Indiana, United States, 46016
    - Furiex research site
  - Bloomington, Indiana, United States, 47403
    - Furiex research site
  - Evansville, Indiana, United States, 47714
    - Furiex research site
  - Indianapolis, Indiana, United States, 46205
    - Furiex research site
  - Indianapolis, Indiana, United States, 46237
    - Furiex research site
  - Indianapolis, Indiana, United States, 46250
    - Furiex research site
- Kansas
  - Lenexa, Kansas, United States, 66215
    - Furiex research site
  - Mission, Kansas, United States, 66202
    - Furiex research site
  - Overland Park, Kansas, United States, 66202
    - Furiex research site
  - Overland Park, Kansas, United States, 66215
    - Furiex research site
  - Topeka, Kansas, United States, 66606
    - Furiex research site
  - Wichita, Kansas, United States, 67203
    - Furiex research site
- Kentucky
  - Bowling Green, Kentucky, United States, 42101
    - Furiex research site
  - Lexington, Kentucky, United States, 40504
    - Furiex research site
  - Louisville, Kentucky, United States, 40202
    - Furiex research site
- Louisiana
  - Metairie, Louisiana, United States, 70006
    - Furiex research site
  - Monroe, Louisiana, United States, 71201
    - Furiex research site
  - Opelousas, Louisiana, United States, 70570
    - Furiex research site
  - Shreveport, Louisiana, United States, 71101
    - Furiex research site
  - Shreveport, Louisiana, United States, 71103
    - Furiex research site
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Furiex research site
  - Chevy Chase, Maryland, United States, 20815
    - Furiex research site
  - Hollywood, Maryland, United States, 20636
    - Furiex research site
  - Laurel, Maryland, United States, 20707
    - Furiex research site
  - Lutherville, Maryland, United States, 21093
    - Furiex research site
  - Prince Frederick, Maryland, United States, 20678
    - Furiex research site
  - Rockville, Maryland, United States, 20850
    - Furiex research site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Furiex research site
  - Boston, Massachusetts, United States, 02135
    - Furiex research site
  - Boston, Massachusetts, United States, 02215
    - Furiex research site
  - Brockton, Massachusetts, United States, 02301
    - Furiex research site
  - Hyannis, Massachusetts, United States, 02601
    - Furiex research site
  - Springfield, Massachusetts, United States, 01105
    - Furiex research site
- Michigan
  - Chesterfield, Michigan, United States, 48047
    - Furiex research site
  - Interlochen, Michigan, United States, 49643
    - Furiex research site
  - Kalamazoo, Michigan, United States, 49009
    - Furiex research site
  - Novi, Michigan, United States, 48377
    - Furiex research site
  - Troy, Michigan, United States, 48098
    - Furiex research site
- Minnesota
  - Chaska, Minnesota, United States, 55318
    - Furiex research site
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - Furiex research site
  - Tupelo, Mississippi, United States, 38801
    - Furiex research site
- Missouri
  - Mexico, Missouri, United States, 65265
    - Furiex research site
  - Saint Louis, Missouri, United States, 63141
    - Furiex research site
  - Saint Peters, Missouri, United States, 63376
    - Furiex research site
- Montana
  - Billings, Montana, United States, 59102
    - Furiex research site
  - Bozeman, Montana, United States, 59718
    - Furiex research site
- Nebraska
  - Bellevue, Nebraska, United States, 68005
    - Furiex research site
  - Omaha, Nebraska, United States, 68114
    - Furiex research site
  - Omaha, Nebraska, United States, 68144
    - Furiex research site
- Nevada
  - Henderson, Nevada, United States, 89052
    - Furiex research site
  - Las Vegas, Nevada, United States, 89106
    - Furiex research site
  - Las Vegas, Nevada, United States, 89183
    - Furiex research site
- New Jersey
  - Atco, New Jersey, United States, 08044
    - Furiex research site
  - Blackwood, New Jersey, United States, 08012
    - Furiex research site
  - Elizabeth, New Jersey, United States, 07202
    - Furiex research site
  - Marlton, New Jersey, United States, 08053
    - Furiex research site
  - Morristown, New Jersey, United States, 07960
    - Furiex research site
  - South Bound Brook, New Jersey, United States, 08880
    - Furiex research site
  - Vineland, New Jersey, United States, 08360
    - Furiex research site
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Furiex research site
  - Albuquerque, New Mexico, United States, 87108
    - Furiex research site
- New York
  - Binghamton, New York, United States, 13903
    - Furiex research site
  - Brooklyn, New York, United States, 11230
    - Furiex research site
  - Brooklyn, New York, United States, 11214
    - Furiex research site
  - Great Neck, New York, United States, 11023
    - Furiex research site
  - Great Neck, New York, United States, 11021
    - Furiex research site
  - Mineola, New York, United States, 11501
    - Furiex research site
  - New York, New York, United States, 10016
    - Furiex research site
- North Carolina
  - Boone, North Carolina, United States, 28607
    - Furiex research site
  - Chapel Hill, North Carolina, United States, 27599
    - Furiex research site
  - Charlotte, North Carolina, United States, 28209
    - Furiex research site
  - Charlotte, North Carolina, United States, 28277
    - Furiex research site
  - Fayetteville, North Carolina, United States, 28304
    - Furiex research site
  - Greensboro, North Carolina, United States, 27403
    - Furiex research site
  - Greensboro, North Carolina, United States, 27401
    - Furiex research site
  - Greenville, North Carolina, United States, 27834
    - Furiex research site
  - Harrisburg, North Carolina, United States, 28075
    - Furiex research site
  - Hickory, North Carolina, United States, 28602
    - Furiex research site
  - Hickory, North Carolina, United States, 28601
    - Furiex research site
  - High Point, North Carolina, United States, 27262
    - Furiex research site
  - Jacksonville, North Carolina, United States, 28546
    - Furiex research site
  - New Bern, North Carolina, United States, 28562
    - Furiex research site
  - Raleigh, North Carolina, United States, 27609
    - Furiex research site
  - Raleigh, North Carolina, United States, 27612
    - Furiex research site
  - Wilmington, North Carolina, United States, 28401
    - Furiex research site
  - Winston-Salem, North Carolina, United States, 27103
    - Furiex research site
  - Winston-Salem, North Carolina, United States, 27103-3914
    - Furiex research site
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - Furiex research site
  - Fargo, North Dakota, United States, 58104
    - Furiex research site
- Ohio
  - Akron, Ohio, United States, 44302
    - Furiex research site
  - Beachwood, Ohio, United States, 44122
    - Furiex research site
  - Beavercreek, Ohio, United States, 45432
    - Furiex research site
  - Cincinnati, Ohio, United States, 45229
    - Furiex research site
  - Cleveland, Ohio, United States, 44122
    - Furiex research site
  - Columbus, Ohio, United States, 43215
    - Furiex research site
  - Columbus, Ohio, United States, 43214
    - Furiex research site
  - Dayton, Ohio, United States, 45432
    - Furiex research site
  - Franklin, Ohio, United States, 45005
    - Furiex research site
  - Mentor, Ohio, United States, 44060
    - Furiex research site
  - Miamisburg, Ohio, United States, 45342-3705
    - Furiex research site
  - Springfield, Ohio, United States, 45504
    - Furiex research site
  - Wadsworth, Ohio, United States, 44281
    - Furiex research site
- Oklahoma
  - Norman, Oklahoma, United States, 73069
    - Furiex research site
  - Norman, Oklahoma, United States, 73071
    - Furiex research site
  - Oklahoma City, Oklahoma, United States, 73104
    - Furiex research site
  - Oklahoma City, Oklahoma, United States, 73112
    - Furiex research site
  - Yukon, Oklahoma, United States, 73099
    - Furiex research site
- Pennsylvania
  - Dingmans Ferry, Pennsylvania, United States, 18328
    - Furiex research site
  - Hermitage, Pennsylvania, United States, 16148
    - Furiex research site
  - Jenkintown, Pennsylvania, United States, 19046
    - Furiex research site
  - Lancaster, Pennsylvania, United States, 17604
    - Furiex research site
  - Lansdale, Pennsylvania, United States, 19446
    - Furiex research site
  - Newton, Pennsylvania, United States, 18940
    - Furiex research site
  - Sayre, Pennsylvania, United States, 18840
    - Furiex research site
  - Uniontown, Pennsylvania, United States, 15401
    - Furiex research site
  - Washington, Pennsylvania, United States, 15301
    - Furiex research site
- Rhode Island
  - Cumberland, Rhode Island, United States, 02864
    - Furiex research site
  - East Providence, Rhode Island, United States, 02914
    - Furiex research site
  - Warwick, Rhode Island, United States, 02886
    - Furiex research site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Furiex research site
  - Columbia, South Carolina, United States, 29201
    - Furiex research site
  - Columbia, South Carolina, United States, 29203
    - Furiex research site
  - Greer, South Carolina, United States, 29651
    - Furiex research site
  - Mount Pleasant, South Carolina, United States, 29464
    - Furiex research site
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Furiex research site
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Furiex research site
  - Chattanooga, Tennessee, United States, 37421
    - Furiex research site
  - Chattanooga, Tennessee, United States, 37404
    - Furiex research site
  - Germantown, Tennessee, United States, 38138
    - Furiex research site
  - Jackson, Tennessee, United States, 38301
    - Furiex research site
  - Johnson City, Tennessee, United States, 37604
    - Furiex research site
  - Kingsport, Tennessee, United States, 37660
    - Furiex research site
  - Nashville, Tennessee, United States, 37203
    - Furiex research site
  - Nashville, Tennessee, United States, 37205
    - Furiex research site
- Texas
  - Austin, Texas, United States, 78705
    - Furiex research site
  - Bedford, Texas, United States, 76022
    - Furiex research site
  - Colleyville, Texas, United States, 76034
    - Furiex research site
  - El Paso, Texas, United States, 79902
    - Furiex research site
  - Fort Worth, Texas, United States, 76107
    - Furiex research site
  - Fort Worth, Texas, United States, 76108
    - Furiex research site
  - Grand Prairie, Texas, United States, 75052
    - Furiex research site
  - Grapevine, Texas, United States, 76051
    - Furiex research site
  - Houston, Texas, United States, 77074
    - Furiex research site
  - Houston, Texas, United States, 77005
    - Furiex research site
  - Houston, Texas, United States, 77022
    - Furiex research site
  - Houston, Texas, United States, 77030
    - Furiex research site
  - Houston, Texas, United States, 77034
    - Furiex research site
  - Houston, Texas, United States, 77081
    - Furiex research site
  - Houston, Texas, United States, 77090
    - Furiex research site
  - Houston, Texas, United States, 77505
    - Furiex research site
  - Hurst, Texas, United States, 76054
    - Furiex research site
  - Irving, Texas, United States, 75061
    - Furiex research site
  - Lake Jackson, Texas, United States, 77566
    - Furiex research site
  - Marshall, Texas, United States, 75670
    - Furiex research site
  - North Richland Hills, Texas, United States, 76180
    - Furiex research site
  - Odessa, Texas, United States, 79761
    - Furiex research site
  - Plano, Texas, United States, 75074
    - Furiex research site
  - San Antonio, Texas, United States, 78209
    - Furiex research site
  - San Antonio, Texas, United States, 78229
    - Furiex research site
  - San Antonio, Texas, United States, 78258
    - Furiex research site
  - San Antonio, Texas, United States, 78212
    - Furiex research site
  - San Antonio, Texas, United States, 78215
    - Furiex research site
  - Sugar Land, Texas, United States, 77478
    - Furiex research site
  - Sugar Land, Texas, United States, 77479
    - Furiex research site
  - Webster, Texas, United States, 77598
    - Furiex research site
- Utah
  - Logan, Utah, United States, 84341
    - Furiex research site
  - Ogden, Utah, United States, 84405
    - Furiex research site
  - Salt Lake City, Utah, United States, 84109
    - Furiex research site
  - Salt Lake City, Utah, United States, 84121
    - Furiex research site
  - South Jordan, Utah, United States, 84095
    - Furiex research site
  - West Jordan, Utah, United States, 84088
    - Furiex research site
  - West Valley City, Utah, United States, 84120
    - Furiex research site
- Virginia
  - Alexandria, Virginia, United States, 22304
    - Furiex research site
  - Chesapeake, Virginia, United States, 23320
    - Furiex research site
  - Christiansburg, Virginia, United States, 24073
    - Furiex research site
  - Danville, Virginia, United States, 24541
    - Furiex research site
  - Fairfax, Virginia, United States, 22031
    - Furiex research site
  - Virginia Beach, Virginia, United States, 23455
    - Furiex research site
- Washington
  - Mill Creek, Washington, United States, 98012-6316
    - Furiex research site
- Wisconsin
  - Madison, Wisconsin, United States, 53715
    - Furiex research site
  - Milwaukee, Wisconsin, United States, 53226
    - Furiex research site

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

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eluxadoline 5 mg Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.	Drug: Eluxadoline Tablets, orally, twice daily. Other Names: JNJ-27018966
Experimental: Eluxadoline 25 mg Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .	Drug: Eluxadoline Tablets, orally, twice daily. Other Names: JNJ-27018966
Experimental: Eluxadoline 100 mg Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.	Drug: Eluxadoline Tablets, orally, twice daily. Other Names: JNJ-27018966
Experimental: Eluxadoline 200 mg Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.	Drug: Eluxadoline Tablets, orally, twice daily. Other Names: JNJ-27018966
Placebo Comparator: Placebo Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.	Drug: Placebo Matching placebo oral tablets twice daily.

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 at Week 4 Time Frame: Baseline (Week prior to Randomization) to Week 4	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.	Baseline (Week prior to Randomization) to Week 4
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	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.	Baseline (Week prior to Randomization) to Week 12

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	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.	Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12
Change From Baseline in Weekly BSS Scores Time Frame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12	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.	Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
Change From Baseline in the Number of Daily Bowel Movements Time Frame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12	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.	Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
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	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.	Baseline (Week Prior to Randomization) to Weeks 1-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Furiex Pharmaceuticals, Inc

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

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.

Clinical Trials on Irritable Bowel Syndrome

ProgenaBiome

Recruiting

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS

Irritable 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 conditions

United States
Clasado
CR2O B.V.

Recruiting

GOS to Reduce Symptom Severity in IBS (EGIS)

Irritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - Mixed

Belgium, Netherlands, United Kingdom
Istanbul Medipol University Hospital
Tepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaborators

Recruiting

Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome

Irritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Mixed

Turkey
Federal Stare Budgetary Scientific Institution,...
I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...

Completed

Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome

Irritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Mixed

Russian Federation
University of California, Los Angeles

Completed

FODMAP Reintroduction in Irritable Bowel Syndrome

Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel Habits

United States
University of Vienna

Completed

Effects of Fasting and Hydro Colon Therapy Plus Probiotics on GI Microbiota in Intolerances and Irritable Bowel Syndrome (MicFFGAH2013)

Irritable Bowel Disease

Austria
Thomayer University Hospital
Charles University, Czech Republic

Active, not recruiting

Faecal Microbiota Transplantation in Irritable Bowel Syndrome (MISCEAT)

Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome Mixed

Czechia
Shahid Beheshti University of Medical Sciences

Completed

Effect of Cholecalciferol, Soy Isoflavones in Patients With Irritable Bowel Syndrome

Irritable Bowel Disease

Iran, Islamic Republic of
Universidad Autonoma de Chihuahua

Not yet recruiting

To Study the Effect of Short-chain Fructooligosaccharides in Women With Irritable Bowel Syndrome

Irritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
Vasily Isakov
Russian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...

Completed

Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations (Kombucha)

Irritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel Syndrome

Russian Federation

Clinical Trials on Eluxadoline

Allergan

Enrolling by invitation

A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Irritable Bowel Syndrome

United States
Temple University
Allergan

Withdrawn

Investigation of Eluxadoline for Diabetic Diarrhea

Diabetes | Diarrhea | Diabetic Diarrhea

United States
University of North Carolina, Chapel Hill
Allergan

Withdrawn

Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence (ELXDFI)

Diarrhea | Fecal Incontinence | Urge Incontinence | Anal Incontinence | Accidental Bowel Leakage
Allergan

Completed

Eluxadoline Bile Acid Malabsorption (BAM) Study

Irritable Bowel Syndrome With Diarrhea

United States
Allergan

Completed

Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use

Irritable Bowel Syndrome With Diarrhea

United States, Canada
Furiex Pharmaceuticals, Inc

Completed

Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

Irritable Bowel Syndrome

United States, Canada, United Kingdom
AbbVie

Recruiting

Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

Irritable Bowel Syndrome

United States, Canada, Poland, United Kingdom, Hungary, Bulgaria, Netherlands
Furiex Pharmaceuticals, Inc

Completed

Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

Irritable Bowel Syndrome

United States, Canada, Puerto Rico, United Kingdom
University of North Carolina, Chapel Hill
National Institute of Environmental Health Sciences (NIEHS)

Completed

Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure (Gammoz)

Allergic Asthma

United States
John H. Stroger Hospital
Eli Lilly and Company

Completed

Insulin Therapy in the Hospital Comparing Two Protocols

Diabetes Mellitus, Type 2

United States

Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Eluxadoline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations