Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)
Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant IBS patients over a 28-day period.
|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|
- 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.
- 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
|Study Start Date:||May 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
5mg enteric-coated oral hard gelatin capsule, administered twice daily
|Placebo Comparator: Placebo||
placebo as enteric-coated oral hard gelatin capsule, administered twice daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149200
|Quotient Clinical Ltd|
|Edinburgh, United Kingdom|
|Quotient Clinical Ltd|
|Ruddington, United Kingdom|
|Principal Investigator:||Stuart Mair, MB, ChB||Quotient Bioresearch Ltd|