Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)

Phase 2

Completed

• Conditions: Irritable Colon

• Registration Number: NCT00101985
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-01-18
• Study First Submitted QC: 2005-01-18
• Study First Posted: 2005-01-19
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 741

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Determine whether talnetant provided adequate relief from IBS pain and discomfort for at least one of three talnetant dose groups compared with placebo and to determine the safety and tolerability of talnetant in subjects with IBS.

Secondary Outcome Measures

Name	Time	Method
- Explore response among subgroups IBS. - Evaluate positive treatment effects within bowel subgroups. - Compare treatment groups for global improvement of IBS symptoms. - Improvement of IBS pain or discomfort, Quality of Life.

Trial Locations

Locations (1)

GSK Investigational Site