A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objectives of this study are to evaluate the clinical safety and tolerability and to assess the efficacy of 100 mg, 200 mg, and 300 mg BID dextofisopam compared with placebo in female outpatients with diarrhea-predominant or alternating irritable bowel syndrome (IBS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmos
• Treatments: Tofisopam

Criteria

Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Female

Inclusion Criteria:

• 1. Outpatient post-menopausal or no pregnant females,18 to 65 years old

• 2. Irritable bowel syndrome, which meet the Rome III criteria for IBS of the diarrhea-predominant or the alternating subtype

• 3. Able to give informed consent

• 4 Willingness to make daily calls on a touch-tone telephone

Exclusion Criteria:

• 1. Clinically significant abnormality on the screening tests.

• 2. Use of any other investigational drug within 30 days before screening visit.

• 3. Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel habits

• 4. Previous treatment with tofisopam Related drugs.

• 5. History or presence of clinically significant medical disease that might compromise the study or be detrimental to the patient, such as

• 6. Subject has exclusively constipation-predominant IBS.