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
Overview
- Phase
- Phase 2
- Intervention
- TC-6499
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Targacept Inc.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change from baseline in global IBS symptom relief score
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Study is to assess the effectiveness of TC-6499 in the treatment of constipation predominant IBS patients over a 28-day period.
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.
Investigators
Eligibility 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.
Exclusion Criteria
- Not provided
Arms & Interventions
TC-6499
Intervention: TC-6499
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- Weekly number of spontaneous bowel movements (SBM)(28 days)
- Severity of pain, bloating, degree of straining, and stool consistency(28 days)