A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea
Overview
- Phase
- Phase 2
- Intervention
- Eluxadoline
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Furiex Pharmaceuticals, Inc
- Enrollment
- 807
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
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.
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.
Arms & Interventions
Eluxadoline 100 mg
Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
Intervention: Eluxadoline
Eluxadoline 25 mg
Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .
Intervention: Eluxadoline
Eluxadoline 5 mg
Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
Intervention: Eluxadoline
Eluxadoline 200 mg
Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
Intervention: Eluxadoline
Placebo
Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
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
Time Frame: Baseline (Week prior to Randomization) to Week 12
Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. The participant recorded their abdominal pain in a daily diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The participant recorded stool consistency in a daily diary using the BSS 7-point scale where: 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.
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
Time Frame: Baseline (Week prior to Randomization) to Week 4
Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. Abdominal pain was assessed on an 11-point scale where: 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 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.
Secondary Outcomes
- Change From Baseline in the Number of Daily Bowel Movements(Baseline (Week prior to Randomization) to Weeks 4, 8, and 12)
- Change From Baseline in the Weekly Pain Scores(Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12)
- Change From Baseline in Weekly BSS Scores(Baseline (Week prior to Randomization) to Weeks 4, 8, and 12)
- Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time(Baseline (Week Prior to Randomization) to Weeks 1-12)