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Study to assess the effects of adding tegaserod to PPI therapy results in clinically meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on daily PPI therapy alone.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaserod | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of 4 weeks of tegaserod treatment in addition to PPI on clinically meaningful incremental gain in improvement of overall GERD symptoms, based on weekly binary questions. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the sensitivity of three global symptom assessments, including two binary scales and a Likert-type scale along with a composite symptom index (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 |
|---|---|---|---|---|---|---|
| Drug Research Services, Inc | Metairie | Louisiana | 70001 | United States | ||
| The Oklahoma Foundation for Digestive Research |
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| Safety assessment |
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C105050 | tegaserod |
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