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| Sponsor: | Pharmos |
|---|---|
| Information provided by: | Pharmos |
| ClinicalTrials.gov Identifier: | NCT00486876 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome |
Drug: Dextofisopam |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 324 |
| Study Start Date: | June 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
|
|
Experimental: 2
100 mg BID
|
Drug: Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
|
|
Experimental: 3
200 mg BID
|
Drug: Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
|
|
Experimental: 4
300 mg BID
|
Drug: Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Female
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 79 Study Locations| Study Chair: | S Colin Neill | President and CFO, Pharmos |
More Information
| Responsible Party: | President, Pharmos Corporation |
| ClinicalTrials.gov Identifier: | NCT00486876 History of Changes |
| Other Study ID Numbers: | VPI-TOFP-203 |
| Study First Received: | June 13, 2007 |
| Last Updated: | August 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Irritable bowel syndrome Diarrhea predominant Irritable Bowel Syndrome Alternating Irritable Bowel Syndrome |
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Tofisopam Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
