Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (Protocol JNJ-27018966IBS3001)
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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.
Condition or disease
Irritable Bowel Syndrome
Drug: JNJ-27018966Drug: Placebo
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.
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
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
Resource links provided by the National Library of Medicine
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 Outcome Measures
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 ]
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient is 18 to 80 years old
Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria.
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).
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),
If sexually active, be practicing an effective method of birth control.
Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
Patient has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
Patient has a history of diverticulitis within 3 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, or impaired intestinal circulation (eg, aortoiliac disease).
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.