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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01149200

Enrollment

Registered

2010-06-23

Start date

2010-05-31

Completion date

2010-10-31

Last updated

2013-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, IBS-C

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.

Interventions

DRUGTC-6499

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in global IBS symptom relief score	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

Measure	Time frame	Description
Weekly number of spontaneous bowel movements (SBM)	28 days	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	28 days	Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026