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The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered once daily in the morning to patients with NERD or GERD at one dose level for each indication. The study will provide further data on the safety and tolerability of pantoprazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Pantoprazole 20 mg |
|
| 2 | Active Comparator | Pantoprazole 40 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | Efficacy of Pantoprazole |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment | 7 days | |
| Symptom relief rates as measured by ReQuest™ after 7 days of treatment | 7 days |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Mössner, Prof. | Universitätsklinikum Leipzig, Leipzig, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed Deutschland GmbH | Augsburg | 86156 | Germany | |||
| Nycomed Deutschland GmbH |
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| Safety | 7 days |
| Berlin |
| 10117 |
| Germany |
| Nycomed Deutschland GmbH | Brandenburg | 14770 | Germany |
| Nycomed Deutschland GmbH | Cologne | 51067 | Germany |
| Nycomed Deutschland GmbH | Cologne | 51109 | Germany |
| Nycomed Deutschland GmbH | Erlangen | 91054 | Germany |
| Nycomed Deutschland GmbH | Frankfurt | 60488 | Germany |
| Nycomed Deutschland GmbH | Frankfurt | 60569 | Germany |
| Nycomed Deutschland GmbH | Gera | 07548 | Germany |
| Nycomed Deutschland GmbH | Göttingen | 37075 | Germany |
| Nycomed Deutschland GmbH | Greifswald | 17489 | Germany |
| Nycomed Deutschland GmbH | Halle | 06110 | Germany |
| Nycomed Deutschland GmbH | Hamburg | 21075 | Germany |
| Nycomed Deutschland GmbH | Hamburg | 22457 | Germany |
| Nycomed Deutschland GmbH | Ingolstadt | 85049 | Germany |
| Nycomed Deutschland GmbH | Jena | 07747 | Germany |
| Nycomed Deutschland GmbH | Kassel | 34125 | Germany |
| Nycomed Deutschland GmbH | Kiel | 24105 | Germany |
| Nycomed Deutschland GmbH | Leipzig | 04103 | Germany |
| Nycomed Deutschland GmbH | Ludwigsburg | 71640 | Germany |
| Nycomed Deutschland GmbH | Ludwigshafen | 67063 | Germany |
| Nycomed Deutschland GmbH | Lübeck | 23538 | Germany |
| Nycomed Deutschland GmbH | Mainz | 55131 | Germany |
| Nycomed Deutschland GmbH | Marburg | 35043 | Germany |
| Nycomed Deutschland GmbH | Minden | 32427 | Germany |
| Nycomed Deutschland GmbH | München | 81377 | Germany |
| Nycomed Deutschland GmbH | Münster | 48149 | Germany |
| Nycomed Deutschland GmbH | Neubrandenburg | 17036 | Germany |
| Nycomed Deutschland GmbH | Offenbach | 63069 | Germany |
| Nycomed Deutschland GmbH | Oldenburg | 26133 | Germany |
| Nycomed Deutschland GmbH | Recklinghausen | 45655 | Germany |
| Nycomed Deutschland GmbH | Rostock | 18057 | Germany |
| Nycomed Deutschland GmbH | Stade | 21682 | Germany |
| Nycomed Deutschland GmbH | Weimar | 99425 | Germany |
| Nycomed Deutschland GmbH | Wiesbaden | 65189 | Germany |
| 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 |
| 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 |
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