The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00394186




Registration number
NCT00394186
Ethics application status
Date submitted
27/10/2006
Date registered
31/10/2006
Date last updated
18/05/2009

Titles & IDs
Public title
A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)
Scientific 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
Secondary ID [1] 0 0
B3I105940
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Bowel Syndrome (IBS) 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GW427353
Treatment: Drugs - Placebo

Treatment: Drugs: GW427353


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
completion of questionnaires by the subject, determining the average adequate relief rate
Timepoint [1] 0 0
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 [1] 0 0
Blood levels of GW427353
Timepoint [1] 0 0
Week 1, 13
Secondary outcome [2] 0 0
Questionnaire
Timepoint [2] 0 0
Weeks 1, 6, 12, 18, 24
Secondary outcome [3] 0 0
ECG, vital signs, adverse events
Timepoint [3] 0 0
each visit
Secondary outcome [4] 0 0
clinical lab tests
Timepoint [4] 0 0
Weeks 1, 6, 12, 18, 24

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects not meeting the Rome II criteria for the diagnosis of IBS

- Subjects with no stool for 7 days during the screen

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Concord
Recruitment hospital [2] 0 0
GSK Investigational Site - Caboolture
Recruitment hospital [3] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [4] 0 0
GSK Investigational Site - Spring Hill
Recruitment hospital [5] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [6] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [7] 0 0
GSK Investigational Site - Malvern
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4510 - Caboolture
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [4] 0 0
4000 - Spring Hill
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Issoire
Country [2] 0 0
France
State/province [2] 0 0
Les Sables d'Olonne
Country [3] 0 0
France
State/province [3] 0 0
Lille
Country [4] 0 0
France
State/province [4] 0 0
Saint Quentin
Country [5] 0 0
France
State/province [5] 0 0
Vitry sur Seine
Country [6] 0 0
Germany
State/province [6] 0 0
Nordrhein-Westfalen
Country [7] 0 0
Germany
State/province [7] 0 0
Sachsen
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Germany
State/province [9] 0 0
Hamburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00394186
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications