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

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486876
• Other study ID #: VPI-TOFP-203
• Status: Completed
• Phase: Phase 2
• First received: June 13, 2007
• Last updated: August 1, 2011
• Start date: June 2007
• Est. completion date: October 2009

Study information

• Verified date: August 2011
• Source: Pharmos
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks

Locations

Country	Name	City	State
United States	New Mexico Clinical Research & Osteoporosis Center, Inc	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Heartland Research Associates, LLC	Arkansas City	Kansas
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Mount Vernon Clinical Research	Atlanta	Georgia
United States	Perimeter Institute for Clinical Research, Inc. (PICR)	Atlanta	Georgia
United States	Austin Gastroenterology, PA	Austin	Texas
United States	Alliance Clinical Research	Birmingham	Alabama
United States	TriCities Medical Research	Bristol	Tennessee
United States	Meridien Research	Brooksville	Florida
United States	Providence Clinical Research	Burbank	California
United States	Medical Frontiers, LLC	Carlisle	Ohio
United States	Radiant Research, Phoenix Southwest	Chandler	Arizona
United States	ClinSearch	Chattanooga	Tennessee
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	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	Rapid Medical Research, Inc.	Cleveland,	Ohio
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Radiant Research of Dallas-North	Dallas	Texas
United States	Research Across America	Dallas	Texas
United States	Gastrointestinal & Liver Diseases Consultants, PC	Dayton	Ohio
United States	Discovery Clinical Research	Encinitas	California
United States	Cumberland Research Associates, LLC.	Fayetteville	North Carolina
United States	Digestive and Liver Disease Specialists	Garden Grove	California
United States	Memphis Gastroenterology Group	Germantown	Tennessee
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Long Island Gastrointestinal Research Group	Great Neck	New York
United States	Clinical Trials of America, Inc.	Hickory	North Carolina
United States	Clinical Research Associates	Huntsville	Alabama
United States	Rosemark Women Care Specialists	Idaho Falls	Idaho
United States	Gastrointestinal Associates	Jackson	Mississippi
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Gastroenterology Associates	Kingsport	Tennessee
United States	Digestive Disease Specialists	Las Vegas	Nevada
United States	Maryland Digestive Disease Research, LLC	Laurel	Maryland
United States	Genesis Research International	Longwood	Florida
United States	Trover Health System	Madisonville	Kentucky
United States	Well Pharma Medical Research, Corp.	Miami	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	Mobile Medical and Diagnostic Center	Mobile	Alabama
United States	Coastal Carolina Research Center	Mt Pleasant	South Carolina
United States	The Weill Medical College Of Cornell University	New York	New York
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Renstar Medical Research	Ocala	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridan Clinical Research	Omaha	Nebraska
United States	Advance Clinical Research Institute	Orange	California
United States	Community Clinical Trials	Orange	California
United States	Compass Research, LLC	Orlando	Florida
United States	The Clinical Research Center of Northwest Florida	Panama City	Florida
United States	TriValley Primary Care-Pennridge	Perkasie	Pennsylvania
United States	ACCORD Clinical Research, LLC	Port Orange	Florida
United States	National Clinical Recruiters, Inc	Richmond	Virginia
United States	Rockford Gastroenterology Associates	Rockford	Illinois
United States	Northern California Research	Sacramento	California
United States	Gastroenterology Clinic of San Antonio	San Antonio	Texas
United States	Quality Research, Inc.	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Medical Associates Research Group	San Diego	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Arkansas Gastroenterology	Sherwood	Arkansas
United States	Clinical Trials of America	Shreveport	Louisiana
United States	Capital Gastroenterology Consultants, PA	Silver Spring	Maryland
United States	Meridien Research	St. Petersburg	Florida
United States	Toledo Center for Clinical Research	Sylvania	Ohio
United States	Family Practice Center of Wadsworth, Inc.	Wadsworth	Ohio
United States	Rx Clinical Trials	Washington	District of Columbia
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Westlake Medical Research	Westlake Village	California
United States	Heartland Research Associates	Wichita	Kansas
United States	Clinical Trials of America	Winston-Salem	North Carolina
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	Aquilo Research	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pharmos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No