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 Syndrome

Furiex Pharmaceuticals0 sites1,282 target enrollmentJune 20, 2012

Overview

No summary available.

Registry

who.int

Start Date

June 20, 2012

End Date

July 29, 2014

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Furiex Pharmaceuticals

•1\. Patient is a man or woman aged 18 to 80 years, inclusive, at Prescreening.
•2\. Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria as loose (mushy) or watery stools \= 25% and hard or lumpy stools \<25% of bowel movements (see Appendix 6\.2 of the protocol: Rome III Diagnostic Criteria for IBS for a definition of IBS and subtyping by predominant stool pattern).
•3\. Patient has had a colonoscopy performed:
•a. Within 10 years prior to Prescreening if patient is at least 50 years of age (alternatively, a flexible sigmoidoscopy, double contrast barium enema, or CT colonography within the past 5 years is acceptable \[see recommendations of the American Cancer Society])
•b. Since the onset (if applicable) of any of the following alarm features for patients of any age (see Spiller and Thompson, 2010\):
•i. Patient has documented weight loss within the past 6 months;
•ii. Patient has nocturnal symptoms;
•iii. Patient has a familial history of colon cancer; or
•iv. Patient has blood mixed with their stool (excluding any blood from hemorrhoids).
•Note: Patients with any history of alarm features must have documentation within their medical record of the gastrointestinal work up performed.

•1\. Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria (see Appendix 6\.2 of the protocol: Rome III Diagnostic Criteria for IBS for a definition of IBS and subtyping by predominant stool pattern).
•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:
•a. Cholecystectomy with ANY history of post cholecystectomy biliary tract pain. Patients who had a successful cholecystectomy with no post operative biliary tract pain are candidates for the study;
•b. Any abdominal surgery within the 3 months prior to Prescreening;
•c. Patient has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed).
•(Refer to protocol for criteria 6\. to 35\).