Clinical trial NCT00486876: A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
Official title: A Double-Blind, Randomized, Placebo-Controlled Phase 2b Study of 100, 200, and 300 mg BID Dextofisopam in Female Outpatients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Diarrhea predominant Irritable Bowel Syndrome
Alternating Irritable Bowel Syndrome
Lead sponsor: Pharmos
Sponsor class: INDUSTRY
First posted: 2007-06-15
Enrollment: 324
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The percentage of weeks for which patients record adequate overall relief of IBS symptoms during the double blind period (12 weeks of treatment).
timeFrame: June 07 thru August 09
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alliance Clinical Research
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Mobile
country: United States
facility: Mobile Medical and Diagnostic Center
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Phoenix Southwest
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Sherwood
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Encinitas
country: United States
facility: Discovery Clinical Research
state: California
city: Garden Grove
country: United States
facility: Digestive and Liver Disease Specialists
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Orange
country: United States
facility: Advance Clinical Research Institute
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Washington
country: United States
facility: Rx Clinical Trials
state: District of Columbia
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Longwood
country: United States
facility: Genesis Research International
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Panama City
country: United States
facility: The Clinical Research Center of Northwest Florida
state: Florida
city: Port Orange
country: United States
facility: ACCORD Clinical Research, LLC
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research, Inc. (PICR)
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates
state: Illinois
city: Arkansas City
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Madisonville
country: United States
facility: Trover Health System
state: Kentucky
city: Shreveport
country: United States
facility: Clinical Trials of America
state: Louisiana
city: Laurel
country: United States
facility: Maryland Digestive Disease Research, LLC
state: Maryland
city: Silver Spring
country: United States
facility: Capital Gastroenterology Consultants, PA
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Jackson
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Omaha
country: United States
facility: Meridan Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Digestive Disease Specialists
state: Nevada
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center, Inc
state: New Mexico
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: The Weill Medical College Of Cornell University
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC.
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America
state: North Carolina
city: Carlisle
country: United States
facility: Medical Frontiers, LLC
state: Ohio
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Digestive Health Network
state: Ohio
city: Cincinnati
country: United States
facility: Gastroenterology Research Consultants of Greater Cincinnati
state: Ohio
city: Cleveland,
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Gastrointestinal & Liver Diseases Consultants, PC
state: Ohio
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth, Inc.
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Yukon
country: United States
facility: Aquilo Research
state: Oklahoma
city: Perkasie
country: United States
facility: TriValley Primary Care-Pennridge
state: Pennsylvania
city: Mt Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Bristol
country: United States
facility: TriCities Medical Research
state: Tennessee
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology, PA
state: Texas
city: Dallas
country: United States
facility: Radiant Research of Dallas-North
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Clinic of San Antonio
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Chesapeake
country: United States
facility: Professional Place Medical Group, LLC
state: Virginia
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Richmond
country: United States
facility: National Clinical Recruiters, Inc
state: Virginia
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
Study officials:
affiliation: President and CFO, Pharmos
name: S Colin Neill
role: STUDY_CHAIR
References: