A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Dextofisopam
Intervention type(s): Drug
Intervention description(s): capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
Intervention MeSH terms: Tofisopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; Diarrhea predominant Irritable Bowel Syndrome; Alternating Irritable Bowel Syndrome