Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (Protocol JNJ-27018966IBS3002)

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.

2. 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
  • Patient has blood mixed with their stool (excluding blood from hemorrhoids). 3. 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.