Back to resultsProof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
TC-6499
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, IBS-C
Eligibility Criteria
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.
Sites / Locations
- Quotient Clinical Ltd
- Quotient Clinical Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TC-6499
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in global IBS symptom relief score
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.
Secondary Outcome Measures
Weekly number of spontaneous bowel movements (SBM)
The number of spontaneous bowel movements not associated with rescue medication will be assessed through patient self-reports
Severity of pain, bloating, degree of straining, and stool consistency
Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01149200
Brief Title
Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Targacept Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 and 8 subjects will receive matching placebo. There will be a 21-day screening phase before 1st study drug administration on Day 1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, IBS-C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TC-6499
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TC-6499
Intervention Description
5mg enteric-coated oral hard gelatin capsule, administered twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo as enteric-coated oral hard gelatin capsule, administered twice daily
Primary Outcome Measure Information:
Title
Change from baseline in global IBS symptom relief score
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Weekly number of spontaneous bowel movements (SBM)
Description
The number of spontaneous bowel movements not associated with rescue medication will be assessed through patient self-reports
Time Frame
28 days
Title
Severity of pain, bloating, degree of straining, and stool consistency
Description
Severity of pain, bloating, degree of straining, and stool consistency will be assessed through daily patient self-reports
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Mair, MB, ChB
Organizational Affiliation
Quotient Bioresearch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Clinical Ltd
City
Edinburgh
Country
United Kingdom
Facility Name
Quotient Clinical Ltd
City
Ruddington
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)
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