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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1130-9255 | Registry Identifier | WHO |
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The aim of this trial is to evaluate the complete remission of erosive gastroesophageal reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once daily during four-week treatment with an extension treatment for non-responding patients. The study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28 -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux. The study will provide further data on safety and tolerability of pantoprazole magnesium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Pantoprazole | Active Comparator |
| |
| Magnesium Esomeprazole | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Pantoprazole | Drug | 1 capsule daily, 40 mg, orally, 30 minutes before breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparatively evaluation of the clinical efficacy of pantoprazole magnesium and esomeprazole in the treatment of patients with erosive gastroesophageal reflux disease (GERD), considering the proportion of patients in complete remission. | A patient is considered at complete remission if he/she achieved symptoms relief and confirmed endoscopic healing at treatment end. A patient achieves symptoms relief if Reflux Questionnaire-GI score ((ReQuest™) stays below 1,73 for at least the three last consecutive treatment days, that can occur at visit V2 or visit V3 for those that did not achieve complete remission at V2 and repeated the treatment for 4 weeks more. | After 4 treatment weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured | After 4 and 8 treatment weeks | |
| Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Belo Horizonte/MG | Brazil | ||||
| Investigational site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24299323 | Derived | Moraes-Filho JP, Pedroso M, Quigley EM; PAMES Study Group. Randomised clinical trial: daily pantoprazole magnesium 40 mg vs. esomeprazole 40 mg for gastro-oesophageal reflux disease, assessed by endoscopy and symptoms. Aliment Pharmacol Ther. 2014 Jan;39(1):47-56. doi: 10.1111/apt.12540. Epub 2013 Oct 29. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Magnesium Esomeprazole | Drug | 1 capsule daily, 40 mg, orally, 30 minutes before breakfast |
|
| Treatments comparative evaluation for endoscopic healing rate | After 4 and 8 treatment weeks |
| Curitiba/PR |
| Brazil |
| Investigational site | Goiânia/GO | Brazil |
| Investigational site | Porto Alegre/RS | Brazil |
| Investigational site | Ribeirão Preto/SP | Brazil |
| Investigational site | Rio de Janeiro/RJ | Brazil |
| Investigational site | Salvador/BA | Brazil |
| Investigational site | Santo André/SP | Brazil |
| Investigational site | São Paulo/SP | Brazil |
| D004066 | Digestive System Diseases |
| 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 |