Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
NCT ID: NCT01553747
Last Updated: 2018-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1146 participants
INTERVENTIONAL
2012-05-29
2014-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Eluxadoline 75 mg
Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.
Eluxadoline
Oral tablets twice daily
Eluxadoline 100 mg
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.
Eluxadoline
Oral tablets twice daily
Placebo
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.
Placebo
Oral tablets twice daily
Interventions
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Eluxadoline
Oral tablets twice daily
Placebo
Oral tablets twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
2\. Participant has had a colonoscopy performed:
* Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)
* Since the onset (if applicable) of any of the following alarm features for participants of any age
* Participant has documented weight loss within the past 6 months
* Participant has nocturnal symptoms
* Participant has a familial history of first-degree relatives with colon cancer
* Participant has blood mixed with their stool (excluding blood from hemorrhoids).
3\. Female participants must be:
* Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
* Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
* Abstinent, or
* If sexually active, be practicing an effective method of birth control.
Exclusion Criteria
2. Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
3. Participant has a history of diverticulitis within 3 months prior to Prescreening.
4. Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
5. Participant has any of the following surgical history:
* Cholecystectomy with any history of post cholecystectomy biliary tract pain
* Any abdominal surgery within the 3 months prior to Prescreening
* Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)
Other protocol-specific eligibility criteria may apply.
18 Years
80 Years
ALL
No
Sponsors
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Furiex Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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Furiex Research Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Decatur, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Sheffield, Alabama, United States
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Tuscaloosa, Alabama, United States
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Glendale, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Sherwood, Arkansas, United States
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Anaheim, California, United States
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Chula Vista, California, United States
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Encinitas, California, United States
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Garden Grove, California, United States
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Huntington Beach, California, United States
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Irvine, California, United States
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La Mesa, California, United States
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La Mirada, California, United States
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Laguna Hills, California, United States
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Lakewood, California, United States
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Lincoln, California, United States
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Loma Linda, California, United States
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Lomita, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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North Hollywood, California, United States
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Northridge, California, United States
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Pasadena, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Boca Raton, Florida, United States
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Boynton Beach, Florida, United States
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Bradenton, Florida, United States
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Brooksville, Florida, United States
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Clearwater, Florida, United States
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Cooper City, Florida, United States
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Coral Springs, Florida, United States
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Eustis, Florida, United States
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Fort Lauderdale, Florida, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Lauderdale Lakes, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miramar, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Plant City, Florida, United States
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Port Orange, Florida, United States
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South Miami, Florida, United States
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St. Petersburg, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Wellington, Florida, United States
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Winter Haven, Florida, United States
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Winter Park, Florida, United States
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Alpharetta, Georgia, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Dunwoody, Georgia, United States
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Lawrenceville, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Norcross, Georgia, United States
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Savannah, Georgia, United States
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Stockbridge, Georgia, United States
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Boise, Idaho, United States
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Eagle, Idaho, United States
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Idaho Falls, Idaho, United States
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Addison, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evergreen Park, Illinois, United States
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Hammond, Illinois, United States
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Springfield, Illinois, United States
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Brownsburg, Indiana, United States
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Evansville, Indiana, United States
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Granger, Indiana, United States
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Clive, Iowa, United States
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Pratt, Kansas, United States
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Shawnee Mission, Kansas, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Paducah, Kentucky, United States
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Lake Charles, Louisiana, United States
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Monroe, Louisiana, United States
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Hagerstown, Maryland, United States
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Hollywood, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Brockton, Massachusetts, United States
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Watertown, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Bay City, Michigan, United States
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Cadillac, Michigan, United States
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Grand Rapids, Michigan, United States
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Kalamazoo, Michigan, United States
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Troy, Michigan, United States
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Ypsilanti, Michigan, United States
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Plymouth, Minnesota, United States
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Biloxi, Mississippi, United States
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City of Saint Peters, Missouri, United States
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Hazelwood, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Bellevue, Nebraska, United States
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Elkhorn, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Lebanon, New Hampshire, United States
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Blackwood, New Jersey, United States
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Edison, New Jersey, United States
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Elizabeth, New Jersey, United States
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Marlton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Flushing, New York, United States
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Hollis, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Dunn, North Carolina, United States
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Greensboro, North Carolina, United States
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Huntersville, North Carolina, United States
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Kinston, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Beavercreek, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Groveport, Ohio, United States
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Kettering, Ohio, United States
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Lima, Ohio, United States
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Tiffin, Ohio, United States
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Toledo, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Carnegie, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Scottdale, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Anderson, South Carolina, United States
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Columbia, South Carolina, United States
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Columbia, South Carolina, United States
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Columbia, South Carolina, United States
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Easley, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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North Myrtle Beach, South Carolina, United States
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Rapid City, South Dakota, United States
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Athens, Tennessee, United States
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Chattanooga, Tennessee, United States
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Columbia, Tennessee, United States
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Jackson, Tennessee, United States
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Knoxville, Tennessee, United States
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Smyrna, Tennessee, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bedford, Texas, United States
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Corsicana, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Frisco, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Hurst, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Bountiful, Utah, United States
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Salt Lake City, Utah, United States
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West Valley City, Utah, United States
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Burlington, Vermont, United States
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Alexandria, Virginia, United States
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Christiansburg, Virginia, United States
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Midlothian, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Charleston, West Virginia, United States
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Monroe, Wisconsin, United States
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Kelowna, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Burlington, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hawkesbury, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Vaughan, Ontario, Canada
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San Juan, , Puerto Rico
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Chestfield, Kent, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Birmingham, , United Kingdom
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County Durham, , United Kingdom
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Coventry, , United Kingdom
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Durham, , United Kingdom
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Edinburgh, , United Kingdom
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Manchester, , United Kingdom
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Sheffield, , United Kingdom
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Wigan, , United Kingdom
Countries
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References
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Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1021-1029.e6. doi: 10.1016/j.cgh.2017.01.026. Epub 2017 Feb 3.
Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.
Other Identifiers
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2012-001601-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
27018966IBS3002
Identifier Type: -
Identifier Source: org_study_id
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