NCT01149200

Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof-of-Principle Study to Evaluate the Safety, Tolerability, and Efficacy of TC-6499-12 in the Treatment of Constipation Predominant IBS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Targacept Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant IBS patients over a 28-day period.

Detailed description

This is a randomized, double blind, placebo controlled study of a maximum of 24 subjects with constipation predominant irritable bowel syndrome (IBS-C). Sixteen subjects will receive active treatment and 8 subjects will receive matching placebo. There will be a 21-day screening phase before 1st study drug administration on Day 1.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	TC-6499	5mg enteric-coated oral hard gelatin capsule, administered twice daily
DRUG	Placebo	placebo as enteric-coated oral hard gelatin capsule, administered twice daily

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-06-23
• Last updated: 2013-12-02

Locations

2 sites across 1 country: United Kingdom