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This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaserod | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of postprandial fullness early satiety and bloating) |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly assessment of satisfactory relief of dyspepsia. | ||
| Daily assessment of percentage of patients responding on average severity score. | ||
| For each week assessment of average daily severity score. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | East Hanover NJ | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936-108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18616658 | Result | Vakil N, Laine L, Talley NJ, Zakko SF, Tack J, Chey WD, Kralstein J, Earnest DL, Ligozio G, Cohard-Radice M. Tegaserod treatment for dysmotility-like functional dyspepsia: results of two randomized, controlled trials. Am J Gastroenterol. 2008 Aug;103(8):1906-19. doi: 10.1111/j.1572-0241.2008.01953.x. Epub 2008 Jul 4. |
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| ID | Term |
|---|---|
| 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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| Percentage of days with satisfactory relief of dyspepsia during each week. |
| Weekly global assessment of change in dyspepsia condition. |
| Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting. |
| Quality of life at end of treatment compared to baseline. |
| Safety and tolerability. |