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Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaserod | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline) | ||
| To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments) |
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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 |
|---|---|---|---|---|---|---|
| Consultants for Clinical Research of South Florida | Boynton Beach | Florida | 33426 | United States | ||
| Miami Research Associates |
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| To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients |
| To assess patient satisfaction with treatment (end of treatment) |
| Miami |
| Florida |
| 33173 |
| United States |
| University Clinical Research | Pembroke Pines | Florida | 33024 | United States |
| Department of Internal Medicine - Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| The Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53207 | United States |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| 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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