Trial Information

Summary: Toledo Center for Clinical Research is currently enrolling in a study for women ages 18 to 65 with diarrhea predominant or alternating irritable bowel syndrome (IBS)

A Double-Blind, Randomized, Placebo-Controlled Phase 2b Study of 100, 200, and 300 mg BID Dextofisopam in Female Outpatients with Irritable Bowel Syndrome.

The purpose of this study is to determine the safety, tolerability and effectiveness of a range of oral doses of the investigational medication, dextofisopam in women with diarrhea predominant or alternating irritable bowel syndrome. The study will last up to 19 weeks, including 14 to 17 days of screening, a 7 day procedure window, 12 weeks of study drug dosing and 28 days of follow-up. At least 6 visits to the office will be required.

Inclusion Criteria:

• Female age 18 to 65?
• Willing to use birth control during the study
• Are you able to speak and read English?

Exclusion Criteria:

• Exclusion – subjects are excluded if they say “yes”
• Do any of the following apply to you?
• Previous treatment with tofisopam, levotofisopam or dextofisopam
• Significant, uncontrolled health condition
• Malignancy in the past 5 years
• Head trauma with loss of consciousness in the past 10 years
• MI, PVD, DVT or cerebrovascular event in the past 5 years
• Suicidal ideation in the past 2 years
• Seizure disorder
• Bipolar disorder or any psychotic disorder

For more information,

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