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

November 27, 2013 updated by: Targacept Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom
        • Quotient Clinical LTD
      • Ruddington, United Kingdom
        • Quotient Clinical LTD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
placebo as enteric-coated oral hard gelatin capsule, administered twice daily
EXPERIMENTAL: TC-6499
Drug: TC-6499
5mg enteric-coated oral hard gelatin capsule, administered twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in global IBS symptom relief score
Time Frame: 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.
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Targacept Inc.

Investigators

  • Principal Investigator: Stuart Mair, MB, ChB, Quotient Bioresearch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (ESTIMATE)

June 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-6499-12-CLP-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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