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

Targacept Inc.24 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

TC-6499DRUG

5mg enteric-coated oral hard gelatin capsule, administered twice daily

PlaceboDRUG

placebo as enteric-coated oral hard gelatin capsule, administered twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Quotient Clinical Ltd

Edinburgh, United Kingdom

Quotient Clinical Ltd

Ruddington, United Kingdom

Outcomes

Primary Outcomes

Change from baseline in global IBS symptom relief score

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.

Time frame: 28 days

Secondary Outcomes

Weekly number of spontaneous bowel movements (SBM)

The number of spontaneous bowel movements not associated with rescue medication will be assessed through patient self-reports

Time frame: 28 days

Severity of pain, bloating, degree of straining, and stool consistency

Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports

Time frame: 28 days

Data from ClinicalTrials.gov

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