Clinical trial NCT00394186: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: GW427353
b3-Adrenergic Receptor Agonist
Irritable Bowel Syndrome (IBS)
efficacy
tolerability
pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: completion of questionnaires by the subject, determining the average adequate relief rate
timeFrame: during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)
Secondary outcomes:
measure: Blood levels of GW427353
timeFrame: Week 1, 13
measure: Questionnaire
timeFrame: Weeks 1, 6, 12, 18, 24
measure: ECG, vital signs, adverse events
timeFrame: each visit
measure: clinical lab tests
timeFrame: Weeks 1, 6, 12, 18, 24
Other outcomes:
Locations:
city: Concord
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Caboolture
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Spring Hill
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Malvern
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Issoire
country: France
facility: GSK Investigational Site
city: Les Sables d'Olonne
country: France
facility: GSK Investigational Site
city: Lille
country: France
facility: GSK Investigational Site
city: Saint Quentin
country: France
facility: GSK Investigational Site
city: Vitry sur Seine
country: France
facility: GSK Investigational Site
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: