Clinical Trial: Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (Protocol JNJ-27018966IBS3002)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel
Brief Summary: The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 compared with placebo in the treatment of patients with diarrhea-predominant irritable bowel syndrome.
Detailed Summary: The study will consist of a pretreatment phase (consisting of an up to 1-week prescreening period and an up to 3-week screening period) and a 30-week blinded treatment period.
Sponsor: Furiex Pharmaceuticals, Inc
Current Primary Outcome: Composite response based on improvements from baseline in daily abdominal pain and daily stool consistency scores. [ Time Frame: Daily response determined to evaluate composite response over 12 weeks ]
Original Primary Outcome:
- Composite response based on improvements from baseline in daily abdominal pain scores. [ Time Frame: Daily response determined to evaluate composite response over 12 weeks ]
- Composite response based on improvements from baseline in daily stool consistency scores. [ Time Frame: Daily response determined to evaluate composite response over 12 weeks ]
Current Secondary Outcome:
- Pain response based on improvement from baseline in daily abdominal pain scores. [ Time Frame: Daily pain response determined to evaluate response over 12 weeks ]
- Stool consistency response based on improvement from baseline in daily stool consistency scores. [ Time Frame: Daily stool consistency response determined to evaluate response over 12 weeks ]
- Abdominal bloating [ Time Frame: Daily over 12 and 26 weeks ]
- Bowel movement frequency [ Time Frame: Daily over 12 and 26 weeks ]
- Urgency episodes [ Time Frame: Daily over 12 and 26 weeks ]
- Incontinence episodes [ Time Frame: Daily over 12 and 26 weeks ]
- Irritable Bowel Syndrome global symptom severity response [ Time Frame: Daily over 12 and 26 weeks ]
- Durability of treatment based on composite response in daily abdominal pain scores. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-26 ]
- Durability of treatment based on the composite response in daily stool consistency scores. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-26 ]
- Durability of treatment based on the composite response in Irritable Bowel Syndrome global symptom severity. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-12, Weeks 1-26 ]
Original Secondary Outcome:
- Pain response based on improvement from baseline in daily abdominal pain scores [ Time Frame: Daily pain response determined to evaluate response rates over 12 weeks ]
- Stool consistency response based on improvement from baseline in daily stool consistency scores. [ Time Frame: Daily stool consistency response determined to evaluate response over 12 weeks ]
- Abdominal bloating [ Time Frame: Daily for 12 weeks ]
- Bowel movement frequency [ Time Frame: Daily for 12 weeks ]
- Urgency episodes [ Time Frame: Daily for 12 weeks ]
- Incontinence episodes [ Time Frame: Daily for 12 weeks ]
- Irritable Bowel Syndrome global symptom severity [ Time Frame: Daily for 12 weeks ]
Information By: Furiex Pharmaceuticals, Inc
Dates:
Date Received: March 8, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 26, 2015
Last Verified: April 2015