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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149200
• Other study ID #: TC-6499-12-CLP-004
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2010
• Last updated: November 27, 2013
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2013
• Source: Targacept Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome

Intervention

Drug:
• TC-6499
5mg enteric-coated oral hard gelatin capsule, administered twice daily
• Placebo
placebo as enteric-coated oral hard gelatin capsule, administered twice daily

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical Ltd	Edinburgh
United Kingdom	Quotient Clinical Ltd	Ruddington

Sponsors (1)

Lead Sponsor	Collaborator
Targacept Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in global IBS symptom relief score	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.	28 days	No
Secondary	Weekly number of spontaneous bowel movements (SBM)	The number of spontaneous bowel movements not associated with rescue medication will be assessed through patient self-reports	28 days	No
Secondary	Severity of pain, bloating, degree of straining, and stool consistency	Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports	28 days	No