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This study was designed is to examine the idea that GW679769 has an effect on three of the pathophysiological disturbances reported in patients with Functional Dyspepsia (FD): impaired stomach accommodation to a meal, delayed stomach emptying, and visceral hypersensitivity to distension.
An exploratory study to investigate the effects of the NK1 antagonist GW679769, 120 mg once daily for 4 days, on gastric accommodation, gastric emptying and gastric distension-induced perception and discomfort in adult male and female patients with functional dyspepsia, in a single-centre, placebo-controlled, double-blind, randomised, two-period crossover study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW679769 | Experimental | 120mg once a day |
|
| Placebo | Placebo Comparator | Placebo once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 oral tablets | Drug | 2x GW679769 60mg tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To identify whether GW679769 has an effect on gastric accommodation to a meal, as measured by gastric barostat in male and female patients with FD. Meal induced fundus relaxation as measured by gastric barostat. | Three to Five Days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of gastric emptying as measured by dual breath test.Thresholds for perception and discomfort during gastric distension by gastric barostat. | Three to Five days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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| Drug |
Placebo oral tablets to match experimental intervention |
|