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
1 other identifier
interventional
807
1 country
288
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2010
Shorter than P25 for phase_2
288 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2010
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
May 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2011
CompletedResults Posted
Study results publicly available
October 22, 2019
CompletedOctober 22, 2019
September 1, 2019
1.2 years
May 24, 2010
August 22, 2019
September 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
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 Outcomes (4)
Change From Baseline in the Weekly Pain Scores
Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12
Change From Baseline in Weekly BSS Scores
Baseline (Week prior to Randomization) to Weeks 4, 8, and 12
Change From Baseline in the Number of Daily Bowel Movements
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
Baseline (Week Prior to Randomization) to Weeks 1-12
Study Arms (5)
Eluxadoline 5 mg
EXPERIMENTALEluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline 25 mg
EXPERIMENTALEluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .
Eluxadoline 100 mg
EXPERIMENTALEluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline 200 mg
EXPERIMENTALEluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
Placebo
PLACEBO COMPARATOREluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
Interventions
Tablets, orally, twice daily.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (288)
Furiex Research Site
Anniston, Alabama, 36207, United States
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Birmingham, Alabama, 35216, United States
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Birmingham, Alabama, 35235, United States
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Dothan, Alabama, 36305, United States
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Huntsville, Alabama, 35801, United States
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Huntsville, Alabama, 35802, United States
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Mobile, Alabama, 36693, United States
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Montgomery, Alabama, 36109, United States
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Pell City, Alabama, 35128, United States
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Chandler, Arizona, 85224, United States
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Glendale, Arizona, 85308, United States
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Mesa, Arizona, 85203, United States
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Phoenix, Arizona, 85018, United States
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Phoenix, Arizona, 85020, United States
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Phoenix, Arizona, 85050, United States
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Tempe, Arizona, 85282, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, 85704, United States
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Tucson, Arizona, 85710, United States
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Jonesboro, Arkansas, 72401, United States
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Little Rock, Arkansas, 72211, United States
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Searcy, Arkansas, 72143, United States
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Sherwood, Arkansas, 72120, United States
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Aliso Viejo, California, 92656, United States
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Anaheim, California, 92801, United States
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Azusa, California, 91702, United States
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Burbank, California, 91505, United States
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Carlsbad, California, 92008, United States
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Encinitas, California, 92024, United States
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Garden Grove, California, 92840, United States
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Garden Grove, California, 92843, United States
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Inglewood, California, 90301, United States
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Laguna Hills, California, 92653, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90015, United States
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Los Angeles, California, 90045, United States
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Murrieta, California, 92562, United States
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Oakland, California, 94609, United States
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Orange, California, 92869, United States
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Sacramento, California, 95825, United States
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San Carlos, California, 94070, United States
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San Diego, California, 92103-6204, United States
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San Diego, California, 92120, United States
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Colorado Springs, Colorado, 80904, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80920, United States
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Colorado Springs, Colorado, 80922, United States
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Denver, Colorado, 80222, United States
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Denver, Colorado, 80239, United States
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Lakewood, Colorado, 80215, United States
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Littleton, Colorado, 80120, United States
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Thornton, Colorado, 80229, United States
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Bristol, Connecticut, 06010, United States
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Waterbury, Connecticut, 06708, United States
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Aventura, Florida, 33916, United States
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Boca Raton, Florida, 33428, United States
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Boca Raton, Florida, 33432, United States
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Bradenton, Florida, 34208, United States
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Brandon, Florida, 33511, United States
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Chipley, Florida, 32428, United States
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DeLand, Florida, 32720, United States
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Delray Beach, Florida, 33484, United States
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Doral, Florida, 33172, United States
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Fort Lauderdale, Florida, 33306, United States
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Hialeah, Florida, 33013, United States
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Hialeah, Florida, 33016, United States
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Inverness, Florida, 34452, United States
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Jacksonville, Florida, 32209, United States
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Jacksonville, Florida, 32256, United States
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Jupiter, Florida, 33458, United States
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Kissimmee, Florida, 34741, United States
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Largo, Florida, 33777, United States
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Lauderdale Lakes, Florida, 33319, United States
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Melbourne, Florida, 32935, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33155, United States
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Naples, Florida, 34102, United States
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Naples, Florida, 34109, United States
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New Port Richey, Florida, 34652, United States
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New Port Richey, Florida, 34655, United States
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New Smyrna Beach, Florida, 32168, United States
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Orlando, Florida, 32837, United States
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Plantation, Florida, 33317, United States
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Port Orange, Florida, 32129, United States
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South Miami, Florida, 33143, United States
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St. Petersburg, Florida, 33709, United States
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Tampa, Florida, 33606, United States
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Tampa, Florida, 33613, United States
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Atlanta, Georgia, 30312, United States
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Atlanta, Georgia, 30338, United States
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Columbus, Georgia, 31904, United States
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Duluth, Georgia, 30096, United States
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Macon, Georgia, 31201, United States
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Marietta, Georgia, 30066, United States
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Newnan, Georgia, 30263, United States
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Rome, Georgia, 30165, United States
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Sandy Springs, Georgia, 30328, United States
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Savannah, Georgia, 31406, United States
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Boise, Idaho, 83702, United States
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Boise, Idaho, 83704, United States
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Idaho Falls, Idaho, 83404, United States
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Meridian, Idaho, 83642, United States
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Nampa, Idaho, 83686, United States
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Champaign, Illinois, 61820, United States
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Chicago, Illinois, 60634, United States
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Morton, Illinois, 61550, United States
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Anderson, Indiana, 46016, United States
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Bloomington, Indiana, 47403, United States
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Evansville, Indiana, 47714, United States
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Indianapolis, Indiana, 46205, United States
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Indianapolis, Indiana, 46237, United States
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Indianapolis, Indiana, 46250, United States
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Lenexa, Kansas, 66215, United States
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Mission, Kansas, 66202, United States
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Overland Park, Kansas, 66202, United States
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Overland Park, Kansas, 66215, United States
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Topeka, Kansas, 66606, United States
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Wichita, Kansas, 67203, United States
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Bowling Green, Kentucky, 42101, United States
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Lexington, Kentucky, 40504, United States
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Louisville, Kentucky, 40202, United States
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Metairie, Louisiana, 70006, United States
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Monroe, Louisiana, 71201, United States
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Opelousas, Louisiana, 70570, United States
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Shreveport, Louisiana, 71101, United States
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Shreveport, Louisiana, 71103, United States
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Annapolis, Maryland, 21401, United States
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Chevy Chase, Maryland, 20815, United States
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Hollywood, Maryland, 20636, United States
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Laurel, Maryland, 20707, United States
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Lutherville, Maryland, 21093, United States
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Prince Frederick, Maryland, 20678, United States
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Rockville, Maryland, 20850, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02135, United States
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Boston, Massachusetts, 02215, United States
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Brockton, Massachusetts, 02301, United States
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Hyannis, Massachusetts, 02601, United States
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Springfield, Massachusetts, 01105, United States
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Chesterfield, Michigan, 48047, United States
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Interlochen, Michigan, 49643, United States
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Kalamazoo, Michigan, 49009, United States
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Novi, Michigan, 48377, United States
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Troy, Michigan, 48098, United States
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Chaska, Minnesota, 55318, United States
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Jackson, Mississippi, 39202, United States
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Tupelo, Mississippi, 38801, United States
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City of Saint Peters, Missouri, 63376, United States
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Mexico, Missouri, 65265, United States
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St Louis, Missouri, 63141, United States
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Billings, Montana, 59102, United States
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Bozeman, Montana, 59718, United States
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Bellevue, Nebraska, 68005, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68144, United States
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Henderson, Nevada, 89052, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89183, United States
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Atco, New Jersey, 08044, United States
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Blackwood, New Jersey, 08012, United States
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Elizabeth, New Jersey, 07202, United States
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Marlton, New Jersey, 08053, United States
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Morristown, New Jersey, 07960, United States
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South Bound Brook, New Jersey, 08880, United States
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Vineland, New Jersey, 08360, United States
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Albuquerque, New Mexico, 87102, United States
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Albuquerque, New Mexico, 87108, United States
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Binghamton, New York, 13903, United States
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Brooklyn, New York, 11214, United States
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Brooklyn, New York, 11230, United States
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Great Neck, New York, 11021, United States
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Great Neck, New York, 11023, United States
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Mineola, New York, 11501, United States
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New York, New York, 10016, United States
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Boone, North Carolina, 28607, United States
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Chapel Hill, North Carolina, 27599, United States
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Charlotte, North Carolina, 28209, United States
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Charlotte, North Carolina, 28277, United States
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Fayetteville, North Carolina, 28304, United States
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Greensboro, North Carolina, 27401, United States
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Greensboro, North Carolina, 27403, United States
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Greenville, North Carolina, 27834, United States
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Harrisburg, North Carolina, 28075, United States
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Hickory, North Carolina, 28601, United States
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Hickory, North Carolina, 28602, United States
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High Point, North Carolina, 27262, United States
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Jacksonville, North Carolina, 28546, United States
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New Bern, North Carolina, 28562, United States
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Raleigh, North Carolina, 27609, United States
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Raleigh, North Carolina, 27612, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103-3914, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58103, United States
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Fargo, North Dakota, 58104, United States
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Akron, Ohio, 44302, United States
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Beachwood, Ohio, 44122, United States
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Beavercreek, Ohio, 45432, United States
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Cincinnati, Ohio, 45229, United States
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Cleveland, Ohio, 44122, United States
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Columbus, Ohio, 43214, United States
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Columbus, Ohio, 43215, United States
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Dayton, Ohio, 45432, United States
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Franklin, Ohio, 45005, United States
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Mentor, Ohio, 44060, United States
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Miamisburg, Ohio, 45342-3705, United States
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Springfield, Ohio, 45504, United States
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Wadsworth, Ohio, 44281, United States
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Norman, Oklahoma, 73069, United States
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Norman, Oklahoma, 73071, United States
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Oklahoma City, Oklahoma, 73104, United States
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Oklahoma City, Oklahoma, 73112, United States
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Yukon, Oklahoma, 73099, United States
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Dingmans Ferry, Pennsylvania, 18328, United States
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Hermitage, Pennsylvania, 16148, United States
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Jenkintown, Pennsylvania, 19046, United States
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Lancaster, Pennsylvania, 17604, United States
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Lansdale, Pennsylvania, 19446, United States
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Newton, Pennsylvania, 18940, United States
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Sayre, Pennsylvania, 18840, United States
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Uniontown, Pennsylvania, 15401, United States
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Washington, Pennsylvania, 15301, United States
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Cumberland, Rhode Island, 02864, United States
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East Providence, Rhode Island, 02914, United States
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Warwick, Rhode Island, 02886, United States
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Anderson, South Carolina, 29621, United States
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Columbia, South Carolina, 29201, United States
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Columbia, South Carolina, 29203, United States
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Greer, South Carolina, 29651, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Rapid City, South Dakota, 57702, United States
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Bristol, Tennessee, 37620, United States
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Chattanooga, Tennessee, 37404, United States
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Chattanooga, Tennessee, 37421, United States
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Germantown, Tennessee, 38138, United States
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Jackson, Tennessee, 38301, United States
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Johnson City, Tennessee, 37604, United States
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Kingsport, Tennessee, 37660, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37205, United States
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Austin, Texas, 78705, United States
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Bedford, Texas, 76022, United States
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Colleyville, Texas, 76034, United States
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El Paso, Texas, 79902, United States
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Fort Worth, Texas, 76107, United States
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Fort Worth, Texas, 76108, United States
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Grand Prairie, Texas, 75052, United States
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Grapevine, Texas, 76051, United States
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Houston, Texas, 77005, United States
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Houston, Texas, 77022, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77034, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77081, United States
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Houston, Texas, 77090, United States
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Houston, Texas, 77505, United States
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Hurst, Texas, 76054, United States
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Irving, Texas, 75061, United States
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Lake Jackson, Texas, 77566, United States
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Marshall, Texas, 75670, United States
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North Richland Hills, Texas, 76180, United States
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Odessa, Texas, 79761, United States
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Plano, Texas, 75074, United States
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San Antonio, Texas, 78209, United States
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San Antonio, Texas, 78212, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Sugar Land, Texas, 77478, United States
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Sugar Land, Texas, 77479, United States
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Webster, Texas, 77598, United States
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Logan, Utah, 84341, United States
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Ogden, Utah, 84405, United States
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Salt Lake City, Utah, 84109, United States
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Salt Lake City, Utah, 84121, United States
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South Jordan, Utah, 84095, United States
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West Jordan, Utah, 84088, United States
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West Valley City, Utah, 84120, United States
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Alexandria, Virginia, 22304, United States
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Chesapeake, Virginia, 23320, United States
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Christiansburg, Virginia, 24073, United States
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Danville, Virginia, 24541, United States
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Fairfax, Virginia, 22031, United States
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Virginia Beach, Virginia, 23455, United States
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Mill Creek, Washington, 98012-6316, United States
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Madison, Wisconsin, 53715, United States
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Milwaukee, Wisconsin, 53226, United States
Related Publications (3)
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.
PMID: 28167156DERIVEDAndrae 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.
PMID: 24813429DERIVEDDove 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.
PMID: 23583433DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2010
First Posted
May 25, 2010
Study Start
April 28, 2010
Primary Completion
July 14, 2011
Study Completion
July 14, 2011
Last Updated
October 22, 2019
Results First Posted
October 22, 2019
Record last verified: 2019-09