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Change of company's strategy
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This superiority phase III study to compare the combination of Pantoprazole and Domperidone with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The hypothesis is that combination of the two medication at the unique capsule is better to the patients because decrease the quantity of times the patients need to take medicines during the day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pantoprazole + Domperidone | Experimental | The combination of pantoprazole and domperidone provided for the study will be the new incremental formulation produced by Eurofarma. For this study will be used doses of capsules containing 20 mg pantoprazole, 20 mg of domperidone. |
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| Pantozol® (Takeda) | Active Comparator | The Pantozol® may be presented in boxes of coated tablets of 20 mg or 40 mg. For this study will be used 20 mg tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole + Domperidone | Drug |
| ||
| Pantozol® |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of pantoprazole + domperidone Eurofarma at the treatment of gastroesophageal reflux disease in relation to the reference drug during 56 days using the score of symptoms | The primary objective of the study is to evaluate the efficacy of combining incremental pantoprazole and domperidone Eurofarma the treatment of gastroesophageal reflux disease in relation to the reference drug. The primary endpoint is the score of symptoms (heartburn and regurgitation) including the severity and frequency after treatment | Evaluation at the gastroesophageal reflux disease in 56 treatment days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life during the study treatment | Evaluation at the gastroesophageal reflux disease in 56 treatment days | |
| Endoscopic cure rate for patients with erosive gastroesophageal reflux disease | Evaluation at the gastroesophageal reflux disease in 56 treatment days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goiania | Goiânia | Goiás | Brazil | |||
| Belo Horizonte |
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| Frequency of adverse events observed | Evaluation at the gastroesophageal reflux disease in 56 treatment days |
| Belo Horizonte |
| Minas Gerais |
| Brazil |
| Curitiba | Curitiba | Paraná | Brazil |
| Rio de Janeiro | Rio de Janeiro | Rio de Janeiro | Brazil |
| Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| Campinas | Campinas | São Paulo | Brazil |
| Jaú | Jaú | São Paulo | Brazil |
| São José do Rio Preto | São José do Rio Preto | São Paulo | Brazil |
| 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 |
|---|---|
| D000077402 | Pantoprazole |
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010880 | Piperidines |
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