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

This study has been completed.
Information provided by (Responsible Party):
Targacept Inc. Identifier:
First received: June 14, 2010
Last updated: November 27, 2013
Last verified: November 2013

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

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: TC-6499
Drug: Placebo
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Targacept Inc.:

Primary Outcome Measures:
  • Change from baseline in global IBS symptom relief score [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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:
  • Weekly number of spontaneous bowel movements (SBM) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports

Enrollment: 24
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TC-6499 Drug: TC-6499
5mg enteric-coated oral hard gelatin capsule, administered twice daily
Placebo Comparator: Placebo Drug: Placebo
placebo as enteric-coated oral hard gelatin capsule, administered twice daily

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01149200

United Kingdom
Quotient Clinical Ltd
Edinburgh, United Kingdom
Quotient Clinical Ltd
Ruddington, United Kingdom
Sponsors and Collaborators
Targacept Inc.
Principal Investigator: Stuart Mair, MB, ChB Quotient Bioresearch Ltd
  More Information

No publications provided

Responsible Party: Targacept Inc. Identifier: NCT01149200     History of Changes
Other Study ID Numbers: TC-6499-12-CLP-004
Study First Received: June 14, 2010
Last Updated: November 27, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Targacept Inc.:
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on April 15, 2014