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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW427353 | Drug | |||
| Placebo | Drug |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of GW427353 | Week 1, 13 | |
| Questionnaire | Weeks 1, 6, 12, 18, 24 | |
| ECG, vital signs, adverse events |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Concord | New South Wales | 2139 | Australia | ||
| GSK Investigational Site |
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| each visit |
| clinical lab tests | Weeks 1, 6, 12, 18, 24 |
| Caboolture |
| Queensland |
| 4510 |
| Australia |
| GSK Investigational Site | Kippa-Ring | Queensland | 4021 | Australia |
| GSK Investigational Site | Spring Hill | Queensland | 4000 | Australia |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| GSK Investigational Site | Box Hill | Victoria | 3128 | Australia |
| GSK Investigational Site | Malvern | Victoria | 3144 | Australia |
| GSK Investigational Site | Issoire | 63500 | France |
| GSK Investigational Site | Les Sables-d'Olonne | 85100 | France |
| GSK Investigational Site | Lille | 59000 | France |
| GSK Investigational Site | Saint-Quentin | 02100 | France |
| GSK Investigational Site | Vitry-sur-Seine | 94400 | France |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 20249 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22143 | Germany |
| GSK Investigational Site | Witten | North Rhine-Westphalia | 58455 | Germany |
| GSK Investigational Site | Leipzg | Saxony | 04109 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10629 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10787 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13125 | Germany |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C523977 | solabegron |
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