Expired Study
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Clinical Trial 15677

tamarac, fl 33319

Study Summary:

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.

Inclusion Criteria:

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: Rome III Diagnostic Criteria for IBS for a definition of IBS and subtyping by predominant stool pattern).

3. Patient has had a colonoscopy performed within 5 years prior to prescreening if they are at least 50 years of age OR if any of the following alarm features are met:

  • Patient has documented weight loss within the past 6 months
  • Patient has nocturnal symptoms
  • Patient has a familial history of colon cancer, or
  • Patient has blood mixed with their stool (excluding any blood from hemorrhoids)

Qualified Participants May Receive:


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.