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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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Keywords

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Irritable Bowel Syndrome IBS-C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TC-6499

Group Type EXPERIMENTAL

TC-6499

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Targacept Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Quotient Clinical Ltd

Ruddington, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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TC-6499-12-CLP-004

Identifier Type: -

Identifier Source: org_study_id