Phase 3
N=1,146
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01553747 ↗Enrolled (actual)
1,146
Serious AEs
1.6%
Results posted
Jul 2018
Primary outcome: Primary: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores — 28.9; 29.6; 16.2 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Eluxadoline (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Furiex Pharmaceuticals, Inc
- Primary completion
- Jan 2014
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 |
30.4; 32.7; 20.2 | 0.001 sig |
| SECONDARY Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores |
30.4; 32.7; 20.2 | 0.001 sig |
| SECONDARY Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals |
48.0; 51.0; 45.3; 47.5; 50.0; 44.8 | — |
| SECONDARY Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals |
37.0; 35.6; 20.9; 34.4; 39.8; 23.6 | — |
| SECONDARY Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals |
43.6; 42.4; 29.6; 45.1; 43.2; 34.3 | — |
| SECONDARY Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale |
45.1; 45.5; 40.1; 48.8; 50.0; 43.7 | — |
| SECONDARY Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale |
60.1; 58.4; 49.2; 52.8; 53.7; 43.7 | — |
| SECONDARY Change From Baseline in Daily Abdominal Discomfort Scores |
-2.44; -2.19; -2.06; -2.88; -2.90; -2.56 | — |
| SECONDARY Change From Baseline in Daily Abdominal Bloating Scores |
-1.89; -1.80; -1.73; -2.24; -2.41; -2.08 | — |
| SECONDARY Number of Bowel Movements Per Day |
3.03; 3.05; 3.38; 2.89; 2.80; 3.15 | — |
| SECONDARY Number of Bowel Incontinence Episodes |
0.47; 0.41; 0.50; 0.40; 0.28; 0.46 | — |
| SECONDARY Number of Bowel Incontinence Free Days |
5.53; 5.46; 5.31; 5.38; 5.56; 5.28 | — |
| SECONDARY Number of Urgency Episodes Per Day |
1.62; 1.58; 2.00; 1.37; 1.32; 1.73 | — |
| SECONDARY Change From Baseline in IBS-QoL Total Scores |
17.51; 17.26; 14.07; 21.60; 21.10; 16.62 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
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 (NCT01553747). 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.