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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Targacept Inc.

ClinicalTrials.gov Identifier:

NCT01149200

First received: June 14, 2010

Last updated: December 12, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 14, 2010

Last Updated Date

December 12, 2011

Start Date ^ICMJE

May 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Global IBS symptom relief score at study day 29 [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

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 (7-point balanced scale "significanly worse" to "significantly relieved") - global score at study 29 as primary endpoint compared to baseline

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01149200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess number of spontaneous bowel movements (SBM) [ Time Frame: Weekly through Day 29 ] [ Designated as safety issue: No ]
The number of spontaneous bowel movements not associated with rescue medication in past 24 hours will be assessed through patient self-reports
Severity of pain, bloating, degree of straining, and stool consistency [ Time Frame: Weekly through Day 29 ] [ Designated as safety issue: No ]
Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports
Safety and tolerability of TC-6499 through adverse event reports [ Time Frame: Weekly through Day 29 ] [ Designated as safety issue: Yes ]
Reports of adverse events associated with TC-6499

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

Study is to assess the effectiveness of TC-6499-12 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 matching placebo. There will be a 21-day screening phase before 1st study drug administration (Visit Day 1), followed by a 28-day out-patient treatment period with 4 additional in-clinic visits (Days 8, 15, 22 and 29).

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Irritable Bowel Syndrome

Intervention ^ICMJE

Drug: TC-6499-12
5mg enteric-coated oral hard gelatin capsule, dose twice-a-day
Drug: Placebo comparator
placebo as enteric-coated oral hard gelatin capsule, dose twice-a-day

Study Arm (s)

Experimental: TC-6499-12
5mg provided in enteric-coated oral hard gelatin capsule

Intervention: Drug: TC-6499-12
Placebo Comparator: Placebo
Intervention: Drug: Placebo comparator

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01149200

Other Study ID Numbers ^ICMJE

PRO-06499-CLP-004(01)

Has Data Monitoring Committee

Responsible Party

Targacept Inc.

Study Sponsor ^ICMJE

Targacept Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stuart Mair, MB, ChB

Quotient Bioresearch Ltd

Information Provided By

Targacept Inc.

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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