Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)
NCT ID: NCT01149200
Last Updated: 2013-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2010-05-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TC-6499
TC-6499
5mg enteric-coated oral hard gelatin capsule, administered twice daily
Placebo
Placebo
placebo as enteric-coated oral hard gelatin capsule, administered twice daily
Interventions
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TC-6499
5mg enteric-coated oral hard gelatin capsule, administered twice daily
Placebo
placebo as enteric-coated oral hard gelatin capsule, administered twice daily
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Targacept Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stuart Mair, MB, ChB
Role: PRINCIPAL_INVESTIGATOR
Quotient Bioresearch
Locations
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Quotient Clinical Ltd
Edinburgh, , United Kingdom
Quotient Clinical Ltd
Ruddington, , United Kingdom
Countries
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Other Identifiers
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TC-6499-12-CLP-004
Identifier Type: -
Identifier Source: org_study_id
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