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

NCT01553747 | Completed Phase 3 Results

• 2 other identifiers: 27018966IBS30022012-001601-24
• Study Type: interventional
• Target: 1,146
• Locations: 4 countries
• Sites: 253

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

Keywords

Irritable bowel syndrome with diarrhea; Irritable bowel syndrome; Diarrhea predominant irritable bowel syndrome; Colonic diseases; Colonic diseases, functional; Digestive system disease; Gastrointestinal disease; Intestinal disease; Colonic pseudo-obstruction; Diarrhea; Signs and symptoms, Digestive

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 participants 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 (13)

• 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 and 30 (End of Treatment [EOT])

Study Arms (3)

Eluxadoline 75 mg

EXPERIMENTAL

Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.

Drug: Eluxadoline

Eluxadoline 100 mg

EXPERIMENTAL

Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.

Drug: Eluxadoline

Placebo

PLACEBO COMPARATOR

Eluxadoline placebo matching tablets, orally, twice daily for up to 26 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 is 18 to 80 years old
• 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
• 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 (253)

Furiex Research Site

Birmingham, Alabama, 35209, United States

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Birmingham, Alabama, 35242, United States

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Decatur, Alabama, 35603, United States

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Montgomery, Alabama, 36109, United States

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Sheffield, Alabama, 35660, United States

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Tuscaloosa, Alabama, 35401, United States

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Glendale, Arizona, 85306, United States

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Glendale, Arizona, 85308, United States

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Mesa, Arizona, 85206, United States

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Phoenix, Arizona, 85023, United States

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Phoenix, Arizona, 85032, United States

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, 85712, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Sherwood, Arkansas, 72120, United States

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Anaheim, California, 92801, United States

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Chula Vista, California, 91910, 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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Huntington Beach, California, 92647, United States

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Irvine, California, 92604, United States

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La Mesa, California, 91942, United States

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La Mirada, California, 90638, United States

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Laguna Hills, California, 92653, United States

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Lakewood, California, 90805, United States

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Lincoln, California, 95648, United States

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Loma Linda, California, 92354, United States

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Lomita, California, 90717, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90045, 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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Northridge, California, 91325, United States

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Pasadena, California, 91105, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92103, United States

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San Diego, California, 92105, United States

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Santa Ana, California, 92701, United States

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Ventura, California, 93003, United States

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Walnut Creek, California, 94598, United States

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Denver, Colorado, 80211, United States

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Denver, Colorado, 80246, United States

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Boca Raton, Florida, 33428, United States

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Boynton Beach, Florida, 33426, United States

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Bradenton, Florida, 34208, United States

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Brooksville, Florida, 34601, United States

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Clearwater, Florida, 33759, 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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Eustis, Florida, 32726, United States

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Fort Lauderdale, Florida, 33308, United States

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Hallandale, Florida, 33009, United States

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Hialeah, Florida, 33016, United States

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Jacksonville, Florida, 32205, United States

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Jupiter, Florida, 33458, United States

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Lauderdale Lakes, Florida, 33319, United States

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Melbourne, Florida, 32901, 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, 33183, United States

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Miramar, Florida, 33025, United States

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New Port Richey, Florida, 34652, United States

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Orlando, Florida, 32806, United States

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Plant City, Florida, 33563, United States

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Port Orange, Florida, 32127, United States

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South Miami, Florida, 33143, United States

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St. Petersburg, Florida, 33705, United States

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St. Petersburg, Florida, 33709, United States

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Tampa, Florida, 33607, United States

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Furiex Research Site

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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Alpharetta, Georgia, 30005, United States

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Athens, Georgia, 30606, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30338, United States

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Dunwoody, Georgia, 30338, United States

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Lawrenceville, Georgia, 30046, United States

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Macon, Georgia, 31201, United States

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Marietta, Georgia, 30066, United States

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Norcross, Georgia, 30092, United States

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Savannah, Georgia, 31404, United States

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Stockbridge, Georgia, 30281, United States

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Boise, Idaho, 83704, United States

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Eagle, Idaho, 83616, United States

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Idaho Falls, Idaho, 83404, United States

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Addison, Illinois, 60101, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60622, United States

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Evergreen Park, Illinois, 60805, United States

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Hammond, Illinois, 46324, United States

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Springfield, Illinois, 62703, United States

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Brownsburg, Indiana, 46112, United States

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Evansville, Indiana, 47714, United States

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Granger, Indiana, 46530, United States

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Clive, Iowa, 50325, United States

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Pratt, Kansas, 67124, United States

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Shawnee Mission, Kansas, 66218, United States

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Topeka, Kansas, 66606, United States

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Lexington, Kentucky, 40503, United States

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Lexington, Kentucky, 40504, United States

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Owensboro, Kentucky, 42303, United States

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Paducah, Kentucky, 42003, United States

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Lake Charles, Louisiana, 70601, United States

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Monroe, Louisiana, 71201, United States

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Hagerstown, Maryland, 21742, United States

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Hollywood, Maryland, 20636, United States

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Furiex Research Site

Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02131, United States

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Brockton, Massachusetts, 02302, 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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Bay City, Michigan, 48706, United States

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Cadillac, Michigan, 49601, United States

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Grand Rapids, Michigan, 49506, United States

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Kalamazoo, Michigan, 49009, United States

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Troy, Michigan, 48098, United States

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Ypsilanti, Michigan, 48197, United States

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Plymouth, Minnesota, 55446, United States

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Biloxi, Mississippi, 39531, United States

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Furiex Research Site

City of Saint Peters, Missouri, 63376, United States

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Furiex Research Site

Hazelwood, Missouri, 63042, United States

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St Louis, Missouri, 63122, 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, 59101, United States

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Bellevue, Nebraska, 68005, United States

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Elkhorn, Nebraska, 68022, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68134, United States

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Furiex Research Site

Omaha, Nebraska, 68144, United States

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Furiex Research Site

Las Vegas, Nevada, 89123, United States

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Reno, Nevada, 89511, United States

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Lebanon, New Hampshire, 03756, United States

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Blackwood, New Jersey, 08012, United States

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Edison, New Jersey, 08817, United States

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Elizabeth, New Jersey, 07201, United States

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Marlton, New Jersey, 08053, 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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Albuquerque, New Mexico, 87109, United States

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Flushing, New York, 11367, United States

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Hollis, New York, 11423, 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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Chapel Hill, North Carolina, 27599, United States

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Dunn, North Carolina, 28334, United States

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Greensboro, North Carolina, 27403, United States

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Huntersville, North Carolina, 28078, United States

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Kinston, North Carolina, 28501, United States

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Wilmington, North Carolina, 28403, United States

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Winston-Salem, North Carolina, 27103, United States

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Winston-Salem, North Carolina, 27106, United States

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Furiex Research Site

Akron, Ohio, 44302, United States

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Furiex Research Site

Beavercreek, Ohio, 45431, United States

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Cincinnati, Ohio, 45224, United States

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Cincinnati, Ohio, 45242, United States

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Cincinnati, Ohio, 45245, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43212, United States

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Furiex Research Site

Columbus, Ohio, 43214, United States

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Furiex Research Site

Columbus, Ohio, 43235, United States

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Dayton, Ohio, 45432, United States

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Dayton, Ohio, 45439, United States

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Groveport, Ohio, 43125, United States

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Kettering, Ohio, 45429, United States

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Lima, Ohio, 45806, United States

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Tiffin, Ohio, 44883, United States

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Toledo, Ohio, 43615, United States

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Norman, Oklahoma, 73071, United States

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Oklahoma City, Oklahoma, 73102, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97210, United States

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Salem, Oregon, 97301, United States

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Carnegie, Pennsylvania, 15106, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Scottdale, Pennsylvania, 15683, United States

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Uniontown, Pennsylvania, 15401, United States

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Warwick, Rhode Island, 02888, 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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Columbia, South Carolina, 29204, United States

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Easley, South Carolina, 29640, United States

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Mt. Pleasant, South Carolina, 29464, United States

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North Myrtle Beach, South Carolina, 29582, United States

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Rapid City, South Dakota, 57702, United States

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Athens, Tennessee, 37303, United States

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Chattanooga, Tennessee, 37404, United States

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Columbia, Tennessee, 38401, United States

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Jackson, Tennessee, 38305, United States

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Knoxville, Tennessee, 37919, United States

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Smyrna, Tennessee, 37167, United States

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Austin, Texas, 78745, United States

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Beaumont, Texas, 77701, United States

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Bedford, Texas, 76021, United States

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Corsicana, Texas, 75110, United States

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Dallas, Texas, 75218, United States

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Dallas, Texas, 75225, United States

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Fort Worth, Texas, 76133, United States

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Frisco, Texas, 75035, United States

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Houston, Texas, 77008, United States

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Houston, Texas, 77043, United States

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Houston, Texas, 77062, United States

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Humble, Texas, 77338, United States

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Hurst, Texas, 76054, 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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Bountiful, Utah, 84010, United States

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Salt Lake City, Utah, 84124, United States

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West Valley City, Utah, 84120, United States

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Burlington, Vermont, 05401, United States

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Alexandria, Virginia, 22304, United States

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Christiansburg, Virginia, 24073, United States

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Midlothian, Virginia, 23114, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23233, United States

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Richmond, Virginia, 23235, United States

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Charleston, West Virginia, 25304, United States

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Monroe, Wisconsin, 53566, United States

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Kelowna, British Columbia, V1Y 3G8, Canada

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St. John's, Newfoundland and Labrador, A1E 2E2, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Greater Sudbury, Ontario, P3E 1H5, Canada

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Hawkesbury, Ontario, K6A 1A1, Canada

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London, Ontario, N5W 6A2, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M6H 3M1, Canada

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Vaughan, Ontario, L4L 4Y7, Canada

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San Juan, 00926-2832, Puerto Rico

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Chestfield, Kent, CT5 3QS, United Kingdom

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Blackpool, Lancashire, FY4 3AD, United Kingdom

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Birmingham, B15 2TH, United Kingdom

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County Durham, DL14 6AD, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Durham, DH1 5TW, United Kingdom

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Edinburgh, EH4 2XH, United Kingdom

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Manchester, M23 9LT, United Kingdom

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Sheffield, S10 2JF, United Kingdom

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Wigan, WN1 2NN, United Kingdom

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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; Colonic Diseases; Colonic Diseases, Functional; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Pseudo-Obstruction; Diarrhea; Signs and Symptoms, Digestive

Interventions

eluxadoline

Condition Hierarchy (Ancestors)

Intestinal Pseudo-Obstruction; Ileus; Intestinal Obstruction; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: January 9, 2014
• Study Completion: January 9, 2014
• Last Updated: July 30, 2018
• Results First Posted: July 30, 2018

Record last verified: 2018-07

Locations

PR (1); CA (10); GB (10); US (232)