Phase 3
Completed N=1,282
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
Source: ClinicalTrials.gov NCT01553591 ↗Enrolled (actual)
1,282
Serious AEs
5.1%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores — 23.9; 25.1; 17.1 percentage of participants — p=0.014
◆ Published Evidence
Highly cited
326citations · ~33 / year
Eluxadoline for Irritable Bowel Syndrome with Diarrhea.
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.
Linked Publications (2)
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Eluxadoline for Irritable Bowel Syndrome with Diarrhea.
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Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores |
23.4; 29.3; 19.0 | 0.112 |
| SECONDARY Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores |
23.4; 29.3; 19.0 | 0.112 |
| SECONDARY Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals |
42.4; 43.2; 39.6; 45.2; 46.5; 43.3 | — |
| SECONDARY Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals |
30.0; 34.3; 22.0; 28.1; 34.0; 24.1 | — |
| SECONDARY Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals |
35.1; 34.7; 28.8; 36.3; 37.1; 32.3 | — |
| SECONDARY Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale |
42.6; 44.1; 37.0; 43.8; 49.8; 41.7 | — |
| SECONDARY Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale |
52.9; 54.2; 43.8; 45.7; 49.5; 40.0 | — |
| SECONDARY Change From Baseline in Daily Abdominal Discomfort Scores |
-2.24; -2.41; -2.01; -2.75; -2.97; -2.61 | — |
| SECONDARY Change From Baseline in Daily Abdominal Bloating Scores |
-1.84; -2.03; -1.72; -2.42; -2.49; -2.16 | — |
| SECONDARY Number of Bowel Movements Per Day |
3.20; 3.20; 3.72; 3.12; 3.09; 3.44 | — |
| SECONDARY Number of Bowel Incontinence Episodes |
0.74; 0.72; 0.93; 0.63; 0.71; 0.94 | — |
| SECONDARY Number of Bowel Incontinence Free Days |
4.83; 4.95; 4.63; 4.96; 4.79; 4.64 | — |
| SECONDARY Number of Urgency Episodes Per Day |
1.75; 1.74; 2.19; 1.55; 1.60; 1.81 | — |
| SECONDARY IBS-QoL Total Scores |
62.37; 64.34; 57.13; 66.22; 67.73; 59.46 | — |
| SECONDARY Change From Baseline in IBS-QoL Total Scores |
16.49; 17.86; 13.25; 19.88; 21.08; 15.76 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01553591) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.