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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Targacept Inc.
ClinicalTrials.gov Identifier:
NCT01149200
First received: June 14, 2010
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

Study is to assess the effectiveness of TC-6499-12 in the treatment of constipation predominant IBS patients over a 28-day period.


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: TC-6499-12
Drug: Placebo comparator
 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:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Targacept Inc.:

Primary Outcome Measures:
  • Global IBS symptom relief score at study day 29 [ Time Frame: Day 29 ] [ 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 (7-point balanced scale "significanly worse" to "significantly relieved") - global score at study 29 as primary endpoint compared to baseline


Secondary Outcome Measures:
  • Assess number of spontaneous bowel movements (SBM) [ Time Frame: Weekly through Day 29 ] [ Designated as safety issue: No ]
    The number of spontaneous bowel movements not associated with rescue medication in past 24 hours will be assessed through patient self-reports

  • Severity of pain, bloating, degree of straining, and stool consistency [ Time Frame: Weekly through Day 29 ] [ Designated as safety issue: No ]
    Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports

  • Safety and tolerability of TC-6499 through adverse event reports [ Time Frame: Weekly through Day 29 ] [ Designated as safety issue: Yes ]
    Reports of adverse events associated with TC-6499


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-6499-12
5mg provided in enteric-coated oral hard gelatin capsule
 Drug: TC-6499-12
5mg enteric-coated oral hard gelatin capsule, dose twice-a-day
Placebo Comparator: Placebo Drug: Placebo comparator
placebo as enteric-coated oral hard gelatin capsule, dose twice-a-day

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 matching placebo. There will be a 21-day screening phase before 1st study drug administration (Visit Day 1), followed by a 28-day out-patient treatment period with 4 additional in-clinic visits (Days 8, 15, 22 and 29).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Targacept Inc.
ClinicalTrials.gov Identifier: NCT01149200     History of Changes
Other Study ID Numbers: PRO-06499-CLP-004(01)
Study First Received: June 14, 2010
Last Updated: December 12, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on May 16, 2013