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

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).

Timeline

Start

2007-06

Primary completion

2009-09

Completion

2009-10

Outcome

Missed primary endpoint

release “The results of the Dextofisopam Phase 2b clinical trial were announced on September 14, 2009. While the trial did not meet” pharmoscorp.com ↗

release “While the trial did not meet the primary endpoints for any of the three drug dose arms” pharmoscorp.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dextofisopam	Small molecule	100 mg	Oral
Subject	Dextofisopam	Small molecule	200 mg	Oral
Subject	Dextofisopam	Small molecule	300 mg	Oral

Indications