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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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).

Key facts

Study ID

NCT00486876

Run by

Pharmos

People needed

324

Starts

2007-06-01

Expected to finish

2009-10-01

Last updated by the study team

2011-08-02

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Mobile Medical and Diagnostic Center — Mobile, Alabama, United States
• Radiant Research, Phoenix Southwest — Chandler, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Arkansas Gastroenterology — Sherwood, Arkansas, United States
• Providence Clinical Research — Burbank, California, United States
• Discovery Clinical Research — Encinitas, California, United States
• Digestive and Liver Disease Specialists — Garden Grove, California, United States
• Community Clinical Trials — Orange, California, United States
• Advance Clinical Research Institute — Orange, California, United States
• Northern California Research — Sacramento, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Westlake Medical Research — Westlake Village, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Rx Clinical Trials — Washington D.C., District of Columbia, United States
• Meridien Research — Brooksville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Genesis Research International — Longwood, Florida, United States
• Well Pharma Medical Research, Corp. — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• The Clinical Research Center of Northwest Florida — Panama City, Florida, United States
• ACCORD Clinical Research, LLC — Port Orange, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Alliance Clinical Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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