NCT00454688

Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: Tioga Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

Detailed description

A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Asimadoline	Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks
DRUG	Placebo	Placebo was provided in coated tablets identical in appearance to asimadoline tablets.

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2007-04-02
• Last updated: 2011-10-18

Locations

112 sites across 1 country: United States