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

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ClinicalTrials.gov Identifier: NCT01149200
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : December 2, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: TC-6499 Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2010
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149200


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

Responsible Party: Targacept Inc.
ClinicalTrials.gov Identifier: NCT01149200     History of Changes
Other Study ID Numbers: TC-6499-12-CLP-004
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013

Keywords provided by Targacept Inc.:
Irritable Bowel Syndrome
IBS-C

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases