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

NCT00486876 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2011-08-02

No results posted yet for this study

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).

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Dextofisopam

capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks

Sponsors & Collaborators

  • Pharmos

    lead INDUSTRY

Principal Investigators

  • S Colin Neill · President and CFO, Pharmos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-09-30
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00486876 on ClinicalTrials.gov