Irritable Bowel Syndrome (IBS)
Conditions
Keywords
GW427353, b3-Adrenergic Receptor Agonist, Irritable Bowel Syndrome (IBS), efficacy, tolerability, pharmacokinetics
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.
Interventions
DRUGGW427353
DRUGPlacebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| completion of questionnaires by the subject, determining the average adequate relief rate | during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2) |
Secondary
| Measure | Time frame |
|---|---|
| Blood levels of GW427353 | Week 1, 13 |
| Questionnaire | Weeks 1, 6, 12, 18, 24 |
| ECG, vital signs, adverse events | each visit |
| clinical lab tests | Weeks 1, 6, 12, 18, 24 |
Countries
Australia, France, Germany
Outcome results
None listed