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A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)

Primary Purpose

Irritable Bowel Syndrome (IBS)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW427353
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Irritable Bowel Syndrome (IBS) focused on measuring GW427353, b3-Adrenergic Receptor Agonist, Irritable Bowel Syndrome (IBS), efficacy, tolerability, pharmacokinetics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain)

Exclusion Criteria:

  • Subjects not meeting the Rome II criteria for the diagnosis of IBS
  • Subjects with no stool for 7 days during the screen

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

completion of questionnaires by the subject, determining the average adequate relief rate

Secondary Outcome Measures

Blood levels of GW427353
Questionnaire
ECG, vital signs, adverse events
clinical lab tests

Full Information

First Posted
October 27, 2006
Last Updated
May 15, 2009
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00394186
Brief Title
A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the Beta-3-Adrenergic Receptor Agonist Solabegron in Subjects With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)
Keywords
GW427353, b3-Adrenergic Receptor Agonist, Irritable Bowel Syndrome (IBS), efficacy, tolerability, pharmacokinetics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW427353
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
GW427353
Primary Outcome Measure Information:
Title
completion of questionnaires by the subject, determining the average adequate relief rate
Time Frame
during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)
Secondary Outcome Measure Information:
Title
Blood levels of GW427353
Time Frame
Week 1, 13
Title
Questionnaire
Time Frame
Weeks 1, 6, 12, 18, 24
Title
ECG, vital signs, adverse events
Time Frame
each visit
Title
clinical lab tests
Time Frame
Weeks 1, 6, 12, 18, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain) Exclusion Criteria: Subjects not meeting the Rome II criteria for the diagnosis of IBS Subjects with no stool for 7 days during the screen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
GSK Investigational Site
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
GSK Investigational Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
GSK Investigational Site
City
Spring Hill
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
GSK Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
GSK Investigational Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
GSK Investigational Site
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
GSK Investigational Site
City
Issoire
ZIP/Postal Code
63500
Country
France
Facility Name
GSK Investigational Site
City
Les Sables d'Olonne
ZIP/Postal Code
85100
Country
France
Facility Name
GSK Investigational Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
GSK Investigational Site
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
GSK Investigational Site
City
Vitry sur Seine
ZIP/Postal Code
94400
Country
France
Facility Name
GSK Investigational Site
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58455
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzg
State/Province
Sachsen
ZIP/Postal Code
04109
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany

12. IPD Sharing Statement

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A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)

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