A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
- Registration Number
- NCT00486876
- Lead Sponsor
- Pharmos
- Brief 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).
- Detailed Description
This is a double-blind, randomized , placebo-controlled Phase 2b study of the safety, tolerability, and efficacy of 100, 200 and 300 mg BID dextofisopam in female patients suffering from diarrhea-predominant or alternating-Irritable Bowel Syndrome. (d-IBS or a-IBS.) Approximately 120 patients will be enrolled in each of the 4 arms of the study which will be conducted in up to 70 clinical sites in the USA. The patients will; be stratified by diagnosis.
Outpatient females, 18 to 65 years old will be enrolled in the study if diagnosed with d-IBS or a-IBS after having been screened during up to 17 days prior to enrollment (including colonoscopy if not done within the last 5 years) and found to have no organic disease that might have caused their complaints of abdominal pain or discomfort which when started was associated with a change in stool frequency or form and/or improves with defecation.
Patients will be instructed to take 3 capsules of the blinded study drug twice a day by mouth and to record by an interactive voice response system (IVRS ) any change in their symptoms. Patients who meet all the Inclusion and Exclusion criteria will be evaluated at baseline (one day prior to taking study drug ) including laboratory determinations including a pregnancy test for women of childbearing potential, vital signs, electrocardiogram ( ECG), recording of adverse events(AE's) and filling out the IBS Quality of Life Questionnaire( IBSQOL ), the Work Productivity and Activity Impairment Questionnaire-IBS Version ( WPAI:IBS )and the Hospital l Anxiety and Depression Questionnaire ( HAD).
Enrolled patients will have 12 weeks of double-blind treatment followed by a 28 day post treatment period.
Symptoms will be recorded daily
. Patients will visit the investigating site at weeks 4, 8 and 12 after the baseline visit and the procedures performed at baseline will be repeated A post treatment visit will occur 28 days after discontinuing study drug. Vital signs, AE's, concomitant medications and daily and weekly symptom assessment via IVRS will be recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 324
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- Outpatient post-menopausal or no pregnant females,18 to 65 years old
-
- Irritable bowel syndrome, which meet the Rome III criteria for IBS of the diarrhea-predominant or the alternating subtype
-
- Able to give informed consent
- 4 Willingness to make daily calls on a touch-tone telephone
-
- Clinically significant abnormality on the screening tests.
-
- Use of any other investigational drug within 30 days before screening visit.
-
- Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel habits
-
- Previous treatment with tofisopam Related drugs.
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- History or presence of clinically significant medical disease that might compromise the study or be detrimental to the patient, such as
-
- Subject has exclusively constipation-predominant IBS.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Dextofisopam 300 mg BID 2 Dextofisopam 100 mg BID 3 Dextofisopam 200 mg BID 1 Dextofisopam Placebo
- Primary Outcome Measures
Name Time Method The percentage of weeks for which patients record adequate overall relief of IBS symptoms during the double blind period (12 weeks of treatment). June 07 thru August 09
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (77)
Mount Vernon Clinical Research
🇺🇸Atlanta, Georgia, United States
Perimeter Institute for Clinical Research, Inc. (PICR)
🇺🇸Atlanta, Georgia, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
The Clinical Research Center of Northwest Florida
🇺🇸Panama City, Florida, United States
Medical Frontiers, LLC
🇺🇸Carlisle, Ohio, United States
Family Practice Center of Wadsworth, Inc.
🇺🇸Wadsworth, Ohio, United States
TriCities Medical Research
🇺🇸Bristol, Tennessee, United States
The Weill Medical College Of Cornell University
🇺🇸New York, New York, United States
Rosemark Women Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
ACCORD Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Maryland Digestive Disease Research, LLC
🇺🇸Laurel, Maryland, United States
Asheville Gastroenterology Associates
🇺🇸Asheville, North Carolina, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Rockford Gastroenterology Associates
🇺🇸Rockford, Illinois, United States
Trover Health System
🇺🇸Madisonville, Kentucky, United States
Aquilo Research
🇺🇸Yukon, Oklahoma, United States
Radiant Research of Dallas-North
🇺🇸Dallas, Texas, United States
Rx Clinical Trials
🇺🇸Washington, District of Columbia, United States
Heartland Research Associates, LLC
🇺🇸Arkansas City, Kansas, United States
New Mexico Clinical Research & Osteoporosis Center, Inc
🇺🇸Albuquerque, New Mexico, United States
TriValley Primary Care-Pennridge
🇺🇸Perkasie, Pennsylvania, United States
Meridien Research
🇺🇸St. Petersburg, Florida, United States
Gastrointestinal Associates
🇺🇸Jackson, Mississippi, United States
Westlake Medical Research
🇺🇸Westlake Village, California, United States
Genesis Research International
🇺🇸Longwood, Florida, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Gastrointestinal & Liver Diseases Consultants, PC
🇺🇸Dayton, Ohio, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland,, Ohio, United States
Gastroenterology Associates
🇺🇸Kingsport, Tennessee, United States
Capital Gastroenterology Consultants, PA
🇺🇸Silver Spring, Maryland, United States
Well Pharma Medical Research, Corp.
🇺🇸Miami, Florida, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Digestive Disease Specialists
🇺🇸Las Vegas, Nevada, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Digestive Health Network
🇺🇸Cincinnati, Ohio, United States
Gastroenterology Research Consultants of Greater Cincinnati
🇺🇸Cincinnati, Ohio, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Gastroenterology Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Mobile Medical and Diagnostic Center
🇺🇸Mobile, Alabama, United States
Radiant Research, Phoenix Southwest
🇺🇸Chandler, 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
Cumberland Research Associates, LLC.
🇺🇸Fayetteville, North Carolina, United States
Clinical Trials of America, Inc.
🇺🇸Hickory, North Carolina, United States
Toledo Center for Clinical Research
🇺🇸Sylvania, Ohio, United States
Coastal Carolina Research Center
🇺🇸Mt Pleasant, South Carolina, United States
Research Across America
🇺🇸Dallas, Texas, United States
Quality Research, Inc.
🇺🇸San Antonio, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
Professional Place Medical Group, LLC
🇺🇸Chesapeake, Virginia, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Long Island Gastrointestinal Research Group
🇺🇸Great Neck, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
Northern California Research
🇺🇸Sacramento, California, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Clinical Trials of America
🇺🇸Winston-Salem, North Carolina, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Meridan Clinical Research
🇺🇸Omaha, Nebraska, United States
Austin Gastroenterology, PA
🇺🇸Austin, Texas, United States
National Clinical Recruiters, Inc
🇺🇸Richmond, Virginia, United States
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States