Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatments jnj-27018966, placebo
Phase phase 3
Sponsor Furiex Pharmaceuticals, Inc
Start date May 2012
End date January 2014
Trial size 1125 participants
Trial identifier NCT01553591, 27018966IBS3001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
jnj-27018966
Oral tablets twice daily
(Experimental)
jnj-27018966
Oral tablets twice daily
(Placebo Comparator)
placebo
Oral tablets twice daily

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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 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 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 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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: 1. Patient is 18 to 80 years old 2. Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria. 3. Patient has had a colonoscopy performed: - Within 10 years prior to Prescreening if patient is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or CT colonography within the past 5 years is acceptable) - Since the onset (if applicable) of any of the following alarm features for patients of any age: - Patient has documented weight loss within the past 6 months - Patient has nocturnal symptoms - Patient has a familial history of first-degree relatives with colon cancer or - Patient has blood mixed with their stool (excluding blood from hemorrhoids). 4. Female patients 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: 1. Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria. 2. Patient has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease. 3. Patient has a history of diverticulitis within 3 months prior to Prescreening. 4. Patient 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). 5. Patient 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 - Patient 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.

Additional Information

Official title A Randomized, Double-blind, Placebo-controled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
Description 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), a 52-week double-blind treatment phase and a 2-week post-treatment follow-up period.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Furiex Pharmaceuticals, Inc.