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Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaserod | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach |
| Measure | Description | Time Frame |
|---|---|---|
| 1) Comparing effects at end of treatment compared to baseline: | ||
| To verify that tegaserod modulates esophageal sensitivity to esophageal distention | ||
| To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18561877 | Derived | Miner PB Jr, Rodriguez-Stanley S, Proskin HM, Kianifard F, Bottoli I. Tegaserod in patients with mechanical sensitivity and overlapping symptoms of functional heartburn and functional dyspepsia. Curr Med Res Opin. 2008 Aug;24(8):2159-72. doi: 10.1185/03007990802222832. Epub 2008 Jun 17. |
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| ID | Term |
|---|---|
| D006356 | Heartburn |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C105050 | tegaserod |
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| To determine if tegaserod improves heartburn and/or regurgitation |
| To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo |
| Safety assessment |
| To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi |