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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: TC-6499; Drug: Placebo

• Registration Number: NCT01149200
• Lead Sponsor: Targacept Inc.

Brief 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Men with IBS-C (ROME III) between 18 and 65 years of age, inclusive.
• Women with IBS-C (ROME III) between 55 and 65 years of age, or 18 to 55 years of age with documentation of non-childbearing potential status (surgical sterilization or one year post last menses with elevated FSH/LV).
• All subjects should have a body mass index (BMI) between 18 and 34 kg/m2, inclusive and a body weight of not less than 45 kg.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TC-6499	TC-6499	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in global IBS symptom relief score	28 days	Primary efficacy endpoint assessed weekly using patient's response to a global symptom relief question rating their relief of IBS symptoms over the past week compared to before study entry.

Secondary Outcome Measures

Name	Time	Method
Weekly number of spontaneous bowel movements (SBM)	28 days	The number of spontaneous bowel movements not associated with rescue medication will be assessed through patient self-reports
Severity of pain, bloating, degree of straining, and stool consistency	28 days	Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports

Trial Locations

Locations (1)

Quotient Clinical Ltd; 🇬🇧 Ruddington, United Kingdom