A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
A Double-Blind, Randomized, Placebo-Controlled Phase 2b Study of 100, 200, and 300 mg BID Dextofisopam in Female Outpatients With Irritable Bowel Syndrome
1 other identifier
interventional
324
1 country
79
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2007
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 13, 2007
CompletedFirst Posted
Study publicly available on registry
June 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedAugust 2, 2011
August 1, 2011
2.3 years
June 13, 2007
August 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
1
PLACEBO COMPARATORPlacebo
2
EXPERIMENTAL100 mg BID
3
EXPERIMENTAL200 mg BID
4
EXPERIMENTAL300 mg BID
Interventions
Eligibility Criteria
You may qualify if:
- \. 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
- Willingness to make daily calls on a touch-tone telephone
You may not qualify if:
- \. 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.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmoslead
Study Sites (79)
Alliance Clinical Research
Birmingham, Alabama, 35215, United States
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Mobile Medical and Diagnostic Center
Mobile, Alabama, 36617, United States
Radiant Research, Phoenix Southwest
Chandler, Arizona, 85225, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Arkansas Gastroenterology
Sherwood, Arkansas, 72120, United States
Providence Clinical Research
Burbank, California, 91505, United States
Discovery Clinical Research
Encinitas, California, 92024, United States
Digestive and Liver Disease Specialists
Garden Grove, California, 92840, United States
Community Clinical Trials
Orange, California, 92868, United States
Advance Clinical Research Institute
Orange, California, 92869, United States
Northern California Research
Sacramento, California, 95831, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Westlake Medical Research
Westlake Village, California, 91361, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909, United States
Rx Clinical Trials
Washington D.C., District of Columbia, 20010, United States
Meridien Research
Brooksville, Florida, 34613, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Genesis Research International
Longwood, Florida, 32779, United States
Well Pharma Medical Research, Corp.
Miami, Florida, 33143, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
The Clinical Research Center of Northwest Florida
Panama City, Florida, 32405, United States
ACCORD Clinical Research, LLC
Port Orange, Florida, 32129, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Mount Vernon Clinical Research
Atlanta, Georgia, 30328, United States
Perimeter Institute for Clinical Research, Inc. (PICR)
Atlanta, Georgia, 30338, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404, United States
Rockford Gastroenterology Associates
Rockford, Illinois, 61101, United States
Heartland Research Associates, LLC
Arkansas City, Kansas, 67005, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Trover Health System
Madisonville, Kentucky, 42431, United States
Clinical Trials of America
Shreveport, Louisiana, 71101, United States
Maryland Digestive Disease Research, LLC
Laurel, Maryland, 20707, United States
Capital Gastroenterology Consultants, PA
Silver Spring, Maryland, 20901, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Gastrointestinal Associates
Jackson, Mississippi, 39202, United States
Meridan Clinical Research
Omaha, Nebraska, 68134, United States
Digestive Disease Specialists
Las Vegas, Nevada, 89128, United States
New Mexico Clinical Research & Osteoporosis Center, Inc
Albuquerque, New Mexico, 87106, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
The Weill Medical College Of Cornell University
New York, New York, 10021, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
Cumberland Research Associates, LLC.
Fayetteville, North Carolina, 28304, United States
Clinical Trials of America, Inc.
Hickory, North Carolina, 28601, United States
Clinical Trials of America
Winston-Salem, North Carolina, 27103, United States
Medical Frontiers, LLC
Carlisle, Ohio, 45005, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Digestive Health Network
Cincinnati, Ohio, 45220, United States
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, 45242, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Gastrointestinal & Liver Diseases Consultants, PC
Dayton, Ohio, 45440, United States
Toledo Center for Clinical Research
Sylvania, Ohio, 43560, United States
Family Practice Center of Wadsworth, Inc.
Wadsworth, Ohio, 44281, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Aquilo Research
Yukon, Oklahoma, 73099, United States
TriValley Primary Care-Pennridge
Perkasie, Pennsylvania, 18944, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
TriCities Medical Research
Bristol, Tennessee, 37620, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
Memphis Gastroenterology Group
Germantown, Tennessee, 38138, United States
Gastroenterology Associates
Kingsport, Tennessee, 37660, United States
Austin Gastroenterology, PA
Austin, Texas, 78745, United States
Radiant Research of Dallas-North
Dallas, Texas, 75231, United States
Research Across America
Dallas, Texas, 75234, United States
Sun Research Institute
San Antonio, Texas, 78205, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
Gastroenterology Clinic of San Antonio
San Antonio, Texas, 78229, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Professional Place Medical Group, LLC
Chesapeake, Virginia, 23320, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
National Clinical Recruiters, Inc
Richmond, Virginia, 23294, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
S Colin Neill
President and CFO, Pharmos
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 13, 2007
First Posted
June 15, 2007
Study Start
June 1, 2007
Primary Completion
September 1, 2009
Study Completion
October 1, 2009
Last Updated
August 2, 2011
Record last verified: 2011-08