Trial Information

Summary: Clinical study for patients with Irritable Bowel Syndrome (IBS)

This study will evaluate the effectiveness and safety of an investigational drug in treating subjects with IBS.

Participants will be asked to:

• Attend up to 8 clinic visits and stay in touch with clinic staff over a period of 3 months. Certain clinic visits include collecting blood, urine or stool samples, a complete physical exam, medical history review, and completing health related questionnaires.
• Make daily calls using a touch-tone phone to an Interactive Voice Response System (IVRS) to report IBS symptoms.
• Follow all instructions of the doctor and study staff, including taking your study medication on time and coming to your scheduled appointments. The study drug is taken by mouth as a tablet. You have a 1 in 4 chance of receiving placebo (inactive tablet) instead of the study drug.
• Use an approved method of birth control and have pregnancy testing completed during the study if you are a woman of childbearing potential. (females only)

If you have not had a colonic examination in the last 2 years a flexible sigmoidoscopy, flexible sigmoidoscopy plus barium enema, or colonoscopy will be performed. If you are eligible for this study and decide to participate, all study medications, study-related medical examinations, and laboratory tests will be provided to you at no cost.

Inclusion Criteria:

• Men and women 18 years or older who have been diagnosed with IBS (either constipation predominant, diarrhea predominant, or non-specific) may qualify for this clinical research study.

You may not qualify for this study if you:

• Have Crohn's disease, ulcerative colitis, or other gastrointestinal conditions that may make study participation unsafe or inappropriate.
• Are pregnant or nursing.

The study staff will review other criteria.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.