Phase 2
N=789
Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01130272 ↗Enrolled (actual)
789
Serious AEs
1.2%
Results posted
Oct 2019
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 at Week 4 — 12.4; 12.0; 11.0; 13.8 percentage of participants — p=0.052
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eluxadoline (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Furiex Pharmaceuticals, Inc
- Primary completion
- Jul 2011
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 at Week 4 |
12.4; 12.0; 11.0; 13.8; 5.7 | 0.052 |
| PRIMARY Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 12 |
8.6; 13.2; 20.2; 15.0; 11.3 | 0.449 |
| SECONDARY Change From Baseline in the Weekly Pain Scores |
5.75; 5.91; 6.11; 5.78; 5.87; -1.76 | — |
| SECONDARY Change From Baseline in Weekly BSS Scores |
6.19; 6.24; 6.22; 6.23; 6.20; -1.09 | — |
| SECONDARY Change From Baseline in the Number of Daily Bowel Movements |
4.55; 4.43; 5.13; 4.99; 4.91; -1.14 | — |
| SECONDARY Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time |
16.5; 20.2; 29.7; 30.6; 19.0; 18.0 | — |
Summary
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).
Eligibility Criteria
Key Inclusion Criteria
- Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
- 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.
Key Exclusion Criteria
- Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
- 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.
Data sourced from ClinicalTrials.gov (NCT01130272). 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.