Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea
NCT ID: NCT01130272
Last Updated: 2019-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
807 participants
INTERVENTIONAL
2010-04-28
2011-07-14
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
QUADRUPLE
Study Groups
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Eluxadoline 5 mg
Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline
Tablets, orally, twice daily.
Eluxadoline 25 mg
Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .
Eluxadoline
Tablets, orally, twice daily.
Eluxadoline 100 mg
Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline
Tablets, orally, twice daily.
Eluxadoline 200 mg
Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
Eluxadoline
Tablets, orally, twice daily.
Placebo
Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
Placebo
Matching placebo oral tablets twice daily.
Interventions
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Eluxadoline
Tablets, orally, twice daily.
Placebo
Matching placebo oral tablets twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 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
Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Huntsville, 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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Pell City, Alabama, United States
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Chandler, 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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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tempe, 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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Searcy, Arkansas, United States
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Sherwood, Arkansas, United States
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Aliso Viejo, California, United States
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Anaheim, California, United States
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Azusa, California, United States
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Burbank, California, United States
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Carlsbad, California, United States
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Encinitas, California, United States
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Garden Grove, California, United States
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Garden Grove, California, United States
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Inglewood, California, United States
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Laguna Hills, 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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Los Angeles, California, United States
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Murrieta, California, United States
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Oakland, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Carlos, 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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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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Littleton, Colorado, United States
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Thornton, Colorado, United States
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Bristol, Connecticut, United States
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Waterbury, Connecticut, United States
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Aventura, Florida, United States
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Boca Raton, Florida, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Chipley, Florida, United States
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DeLand, Florida, United States
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Delray Beach, Florida, United States
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Doral, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Largo, 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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Naples, Florida, United States
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Naples, Florida, United States
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New Port Richey, Florida, United States
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New Port Richey, Florida, United States
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New Smyrna Beach, Florida, United States
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Orlando, Florida, United States
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Plantation, 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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Tampa, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Duluth, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Newnan, Georgia, United States
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Rome, Georgia, United States
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Sandy Springs, Georgia, United States
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Savannah, Georgia, United States
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Boise, Idaho, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Meridian, Idaho, United States
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Nampa, Idaho, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Morton, Illinois, United States
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Anderson, Indiana, United States
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Bloomington, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Lenexa, Kansas, United States
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Mission, Kansas, United States
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Overland Park, Kansas, United States
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Overland Park, Kansas, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Bowling Green, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Monroe, Louisiana, United States
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Opelousas, Louisiana, United States
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Shreveport, Louisiana, United States
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Shreveport, Louisiana, United States
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Annapolis, Maryland, United States
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Chevy Chase, Maryland, United States
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Hollywood, Maryland, United States
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Laurel, Maryland, United States
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Lutherville, Maryland, United States
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Prince Frederick, Maryland, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, 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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Hyannis, Massachusetts, United States
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Springfield, Massachusetts, United States
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Chesterfield, Michigan, United States
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Interlochen, Michigan, United States
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Kalamazoo, Michigan, United States
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Novi, Michigan, United States
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Troy, Michigan, United States
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Chaska, Minnesota, United States
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Jackson, Mississippi, United States
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Tupelo, Mississippi, United States
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City of Saint Peters, Missouri, United States
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Mexico, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Bozeman, Montana, United States
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Bellevue, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Atco, New Jersey, United States
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Blackwood, 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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Morristown, New Jersey, United States
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South Bound Brook, New Jersey, United States
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Vineland, 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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Binghamton, New York, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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Great Neck, 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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Boone, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Fayetteville, North Carolina, United States
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Greensboro, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Harrisburg, North Carolina, United States
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Hickory, North Carolina, United States
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Hickory, North Carolina, United States
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High Point, North Carolina, United States
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Jacksonville, North Carolina, United States
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New Bern, North Carolina, United States
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Raleigh, North Carolina, United States
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Raleigh, 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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Fargo, North Dakota, United States
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Fargo, North Dakota, United States
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Akron, Ohio, United States
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Beachwood, Ohio, United States
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Beavercreek, 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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Dayton, Ohio, United States
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Franklin, Ohio, United States
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Mentor, Ohio, United States
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Miamisburg, Ohio, United States
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Springfield, Ohio, United States
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Wadsworth, Ohio, United States
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Norman, Oklahoma, 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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Yukon, Oklahoma, United States
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Dingmans Ferry, Pennsylvania, United States
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Hermitage, Pennsylvania, United States
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Jenkintown, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Newton, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Washington, Pennsylvania, United States
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Cumberland, Rhode Island, United States
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East Providence, Rhode Island, 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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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Rapid City, South Dakota, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Jackson, Tennessee, United States
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Johnson City, Tennessee, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Colleyville, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Fort Worth, Texas, United States
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Grand Prairie, Texas, United States
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Grapevine, 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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Houston, 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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Houston, Texas, United States
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Hurst, Texas, United States
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Irving, Texas, United States
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Lake Jackson, Texas, United States
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Marshall, Texas, United States
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North Richland Hills, Texas, United States
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Odessa, Texas, United States
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Plano, 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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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Sugar Land, Texas, United States
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Webster, Texas, United States
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Logan, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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South Jordan, Utah, United States
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West Jordan, Utah, United States
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West Valley City, Utah, United States
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Alexandria, Virginia, United States
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Chesapeake, Virginia, United States
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Christiansburg, Virginia, United States
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Danville, Virginia, United States
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Fairfax, Virginia, United States
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Virginia Beach, Virginia, United States
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Mill Creek, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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.
Andrae DA, Covington PS, Patrick DL. Item-level assessment of the irritable bowel syndrome quality of life questionnaire in patients with diarrheal irritable bowel syndrome. Clin Ther. 2014 May;36(5):663-79. doi: 10.1016/j.clinthera.2014.04.009. Epub 2014 May 9.
Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. doi: 10.1053/j.gastro.2013.04.006. Epub 2013 Apr 9.
Other Identifiers
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27018966IBS2001
Identifier Type: -
Identifier Source: org_study_id
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