Status:
COMPLETED
Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)
Lead Sponsor:
Targacept Inc.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01149200
Start Date
May 1 2010
End Date
October 1 2010
Last Update
December 2 2013
Active Locations (2)
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1
Quotient Clinical Ltd
Edinburgh, United Kingdom
2
Quotient Clinical Ltd
Ruddington, United Kingdom