CompletedPhase 2

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

United Kingdom24 participantsStarted 2010-05

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change from baseline in global IBS symptom relief score

Timeframe: 28 days

Trial details

NCT IDNCT01149200

SponsorTargacept Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials