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Completed

NCT Number: NCT01149200

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Quotient Clinical Ltd, Edinburgh, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TC-6499

Drug

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

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Targacept Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2010
Registry last updated
Dec 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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