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

NCT01553591 | Completed Phase 3 Results

• 2 other identifiers: 27018966IBS30012012-001600-38
• Study Type: interventional
• Target: 1,282
• Locations: 3 countries
• Sites: 283

Brief Summary

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores

  Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 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.

  Up to 12 Weeks

Secondary Outcomes (14)

• Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores

  Up to 26 Weeks

• Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals

  12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)

• Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals

  12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)

• Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals

  12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)

• Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale

  Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT])

Study Arms (3)

Eluxadoline 75 mg

EXPERIMENTAL

Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.

Drug: Eluxadoline

Eluxadoline 100 mg

EXPERIMENTAL

Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.

Drug: Eluxadoline

Placebo

PLACEBO COMPARATOR

Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.

Drug: Placebo

Interventions

Eluxadoline DRUG

Oral tablets twice daily

Also known as: JNJ-27018966

Eluxadoline 100 mg; Eluxadoline 75 mg

Placebo DRUG

Oral tablets twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
• 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 or
• Participant has blood mixed with their stool (excluding blood from hemorrhoids).
• 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.

You may not qualify if:

• Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
• 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.
• Participant has a history of diverticulitis within 3 months prior to Prescreening.
• 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).
• 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.

Sponsors & Collaborators

• Furiex Pharmaceuticals, Inc: lead

Study Sites (283)

Furiex Research Site

Athens, Alabama, 35611, United States

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Birmingham, Alabama, 35213, United States

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Foley, Alabama, 36535, United States

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Huntsville, Alabama, 35802, United States

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Ozark, Alabama, 36360, United States

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Chandler, Arizona, 85224, United States

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Glendale, Arizona, 85306, United States

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Mesa, Arizona, 85213, United States

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Phoenix, Arizona, 85018, United States

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Tucson, Arizona, 85712, United States

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Little Rock, Arkansas, 72211, United States

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Little Rock, Arkansas, 72212, United States

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North Little Rock, Arkansas, 72117, United States

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Azusa, California, 91702, United States

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Bell Gardens, California, 90201, United States

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Beverly Hills, California, 90211, United States

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Carson, California, 91105, United States

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Chula Vista, California, 91910, United States

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Corona, California, 92880, United States

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El Cajon, California, 92020, United States

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Encino, California, 91436, United States

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Garden Grove, California, 92843, United States

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Lomita, California, 90717, United States

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Los Angeles, California, 90022, United States

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Monterey Park, California, 91754, United States

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Murrieta, California, 92562, United States

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Newport Beach, California, 92663, United States

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North Hollywood, California, 91606, United States

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Oakland, California, 94612, United States

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Oxnard, California, 93030, United States

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Pismo Beach, California, 93449, United States

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Poway, California, 92064, United States

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Riverside, California, 92501, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95825, United States

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San Diego, California, 92103, United States

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San Diego, California, 92114, United States

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Santa Monica, California, 90404, United States

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Thousand Oaks, California, 91360, 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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Lafayette, Colorado, 80026, United States

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Lakewood, Colorado, 80215, United States

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Longmont, Colorado, 80501, United States

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Norwalk, Connecticut, 06851, United States

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Ridgefield, Connecticut, 06877, United States

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Boca Raton, Florida, 33428, United States

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Brandon, Florida, 33511, United States

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Clearwater, Florida, 33765, United States

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Cooper City, Florida, 33024, United States

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Coral Springs, Florida, 33065, United States

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Crystal River, Florida, 34429, United States

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Doral, Florida, 33172, United States

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Eustis, Florida, 32726, United States

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Furix Research Site

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, 32216, United States

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Kissimmee, Florida, 34741, United States

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Maitland, Florida, 32751, United States

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Melbourne, Florida, 32935, United States

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Miami, Florida, 33015, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33133, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33175, United States

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Miami Springs, Florida, 33166, United States

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Miramar, Florida, 33025, United States

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Naples, Florida, 34102, United States

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New Port Richey, Florida, 34653, United States

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New Smyrna Beach, Florida, 32168, United States

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Orlando, Florida, 32801, United States

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Orlando, Florida, 32806, United States

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Orlando, Florida, 32819, United States

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Ormond Beach, Florida, 32174, United States

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Oviedo, Florida, 32765, United States

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Palm Beach, Florida, 33472, United States

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Pinellas Park, Florida, 33781, United States

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Pinellas Park, Florida, 33782, United States

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Port Orange, Florida, 32129, United States

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Sanford, Florida, 32771, United States

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Sebastian, Florida, 32958, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33607, United States

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Venice, Florida, 34292, United States

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Wellington, Florida, 33414, United States

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Winter Haven, Florida, 33880, United States

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Winter Park, Florida, 32792, United States

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Atlanta, Georgia, 30338, United States

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Blue Ridge, Georgia, 30513, United States

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Johns Creek, Georgia, 30097, United States

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Lilburn, Georgia, 30047, United States

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Oakwood, Georgia, 30566, United States

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Perry, Georgia, 31069, United States

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Snellville, Georgia, 30078, United States

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Eagle, Idaho, 83616, United States

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Addison, Illinois, 60101, United States

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Chicago, Illinois, 60611, United States

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Morton, Illinois, 61550, United States

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Brownsburg, Indiana, 46112, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46202, United States

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Clive, Iowa, 50325, United States

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Davenport, Iowa, 52807, United States

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Iowa City, Iowa, 52242, United States

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West Des Moines, Iowa, 50266, United States

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Newton, Kansas, 67114, United States

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Prairie Village, Kansas, 66206, United States

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Shawnee Mission, Kansas, 66218, United States

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Wichita, Kansas, 67203, United States

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Wichita, Kansas, 67205, United States

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Crestview Hills, Kentucky, 41017, United States

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Hawesville, Kentucky, 42348, United States

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Lexington, Kentucky, 40509, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202, United States

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Madisonville, Kentucky, 42431, United States

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Owensboro, Kentucky, 42303, United States

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Baker, Louisiana, 70794, United States

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Covington, Louisiana, 70435, United States

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Hammond, Louisiana, 70403, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70124, 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, 71105, United States

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Bangor, Maine, 04401, 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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Brockton, Massachusetts, 02301, United States

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Watertown, Massachusetts, 02472, United States

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Ann Arbor, Michigan, 48106, United States

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Southfield, Michigan, 48034, United States

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Stevensville, Michigan, 49127, United States

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Chaska, Minnesota, 55318, United States

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Jackson, Mississippi, 39202, United States

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City of Saint Peters, Missouri, 63376, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63128, 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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Bellevue, Nebraska, 68005, United States

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Omaha, Nebraska, 68114, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89106, United States

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Las Vegas, Nevada, 89119, United States

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Collingswood, New Jersey, 08108, United States

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Edison, New Jersey, 08817, United States

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Albuquerque, New Mexico, 87106, United States

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Brooklyn, New York, 11230, United States

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Endwell, New York, 13760, United States

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Great Neck, New York, 11023, United States

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Hartsdale, New York, 10530, United States

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Kew Gardens, New York, 11415, United States

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New Windsor, New York, 12553, United States

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New York, New York, 10016, United States

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North Massapequa, New York, 11758, United States

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Poughkeepsie, New York, 12601, United States

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Asheville, North Carolina, 28801, United States

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Asheville, North Carolina, 28803, United States

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Charlotte, North Carolina, 28211, United States

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Durham, North Carolina, 27713, United States

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Fayetteville, North Carolina, 28304, United States

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Greensboro, North Carolina, 27403, 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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Kinston, North Carolina, 28501, United States

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Lenoir, North Carolina, 28645, 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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Salisbury, North Carolina, 28144, 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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Beavercreek, Ohio, 45432, United States

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Berea, Ohio, 44017, United States

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Centerville, Ohio, 45459, United States

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Cincinnati, Ohio, 45212, United States

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Cincinnati, Ohio, 45219, United States

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Columbus, Ohio, 43215, United States

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Dayton, Ohio, 45415, United States

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Dayton, Ohio, 45419, United States

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Englewood, Ohio, 45322, United States

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Franklin, Ohio, 45005, United States

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Marion, Ohio, 43302, United States

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Miamisburg, Ohio, 45342, United States

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Middleburg Heights, Ohio, 44130, United States

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Wadsworth, Ohio, 44281, United States

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Zanesville, Ohio, 43701, United States

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Tulsa, Oklahoma, 74104, United States

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Tulsa, Oklahoma, 74135, United States

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Tulsa, Oklahoma, 74136, United States

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Belle Vernon, Pennsylvania, 15012, United States

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Jenkintown, Pennsylvania, 19046, United States

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Johnstown, Pennsylvania, 15905, United States

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Lansdale, Pennsylvania, 19446, United States

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Philadelphia, Pennsylvania, 19142, United States

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Philadelphia, Pennsylvania, 19152, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Uniontown, Pennsylvania, 15401, United States

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Upper Saint Clair, Pennsylvania, 15241, 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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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29406, United States

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Fort Mill, South Carolina, 29707, United States

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Greenville, South Carolina, 29615, United States

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Greer, South Carolina, 29650, United States

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Greer, South Carolina, 29651, United States

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Myrtle Beach, South Carolina, 29588, United States

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Myrtle Beach, South Carolina, 29752, United States

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Simpsonville, South Carolina, 29681, United States

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Summerville, South Carolina, 29485, United States

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Bristol, Tennessee, 37620, United States

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Chattanooga, Tennessee, 37421, United States

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Clarksville, Tennessee, 37043, United States

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Columbia, Tennessee, 38401, United States

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Franklin, Tennessee, 37064, United States

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Johnson City, Tennessee, 37604, United States

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Memphis, Tennessee, 38119, United States

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Smyrna, Tennessee, 37167, United States

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Austin, Texas, 78745, United States

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Austin, Texas, 78756, United States

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Baytown, Texas, 77521, United States

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Beaumont, Texas, 77701, United States

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Dallas, Texas, 75224, United States

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El Paso, Texas, 79905, United States

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Houston, Texas, 77074, United States

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Houston, Texas, 77079, United States

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Houston, Texas, 77089, United States

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Houston, Texas, 77098, United States

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Marshall, Texas, 75670, United States

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Plano, Texas, 75024, United States

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San Antonio, Texas, 78209, 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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Clinton, Utah, 84015, United States

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Draper, Utah, 84020, 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, 84102, United States

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West Jordan, Utah, 84088, United States

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Lynchburg, Virginia, 24502, United States

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Richmond, Virginia, 23219, United States

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Williamsburg, Virginia, 23185, United States

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Spokane, Washington, 99202, United States

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Spokane, Washington, 99204, United States

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Spokane, Washington, 99208, United States

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Wenatchee, Washington, 98801, United States

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Morgantown, West Virginia, 26505, United States

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Wauwatosa, Wisconsin, 53226, United States

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Kamloops, British Columbia, V2C 1K7, Canada

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Kelowna, British Columbia, V1Y 1Z9, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Bridgewater, Nova Scotia, B4V 3N2, Canada

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Halifax, Nova Scotia, B3K 2M5, Canada

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Cambridge, Ontario, N1S 2M6, Canada

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London, Ontario, N6A 5R8, Canada

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Niagara Falls, Ontario, L2G 1J4, Canada

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Oshawa, Ontario, L1H 1B9, Canada

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Chesterfield, Derbyshire, S40 4AA, United Kingdom

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Blackpool, Lancashire, FY3 7EN, United Kingdom

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Thornton-Cleveleys, Lancashire, FY5 3LF, United Kingdom

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Burbage, Leicestershire, LE10 2SE, United Kingdom

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Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom

Location

Furiex Research Site

Chippenham, Wiltshire, SN14 6GT, United Kingdom

Location

Furiex Research Site

Bath, BA2 3HT, United Kingdom

Location

Furiex Research Site

Bath, BA2 4BY, United Kingdom

Location

Furiex Research Site

Coventry, CV6 4DD, United Kingdom

Location

Furiex Research Site

Dorking, RH4 1SD, United Kingdom

Location

Furiex Research Site

Haxey, DN9 2HY, United Kingdom

Location

Furiex Research Site

London, E11 1NR, United Kingdom

Location

Furiex Research Site

Shrewsbury, SY3 8XQ, United Kingdom

Location

Furiex Research Site

Southampton, SO16 6YD, United Kingdom

Location

Furiex Research Site

Strensall, YO32 5UA, United Kingdom

Location

Furiex Research Site

Thornton, FY5 2TZ, United Kingdom

Location

Furiex Research Site

Torpoint, PL11 2JW, United Kingdom

Location

Related Publications (2)

• 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: 28167156 DERIVED

• 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.

  PMID: 26789872 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

eluxadoline

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 14, 2012
• Study Start: May 29, 2012
• Primary Completion: July 29, 2014
• Study Completion: July 29, 2014
• Last Updated: September 4, 2018
• Results First Posted: September 4, 2018

Record last verified: 2018-08

Locations

US (257); CA (9); GB (17)