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The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Pantoprazole 40 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | Symptom Assessment after treatment with Pantoprozole 40 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| symptom assessment as measured by ReQuest™ questionnaire and investigator. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator | 28 days | |
| endoscopic healing after 28 days | 28 days | |
| health-related quality of life after 28 days |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Holtmann, Prof. | Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana Pharma/Nycomed | Bondi Junction | NSW 2022 | Australia | |||
| Altana Pharma/Nycomed |
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| 28 days |
| safety. | 28 days |
| Box Hill, Victoria |
| 3128 |
| Australia |
| Altana Pharma/Nycomed | New South Wales | 2138 | Australia |
| Altana Pharma/Nycomed | South Australia | 5000 | Australia |
| Altana Pharma/Nycomed | Feldbach | 8330 | Austria |
| Altana Pharma/Nycomed | Graz | 8020 | Austria |
| Altana Pharma/Nycomed | Stockerau | 2000 | Austria |
| Altana Pharma/Nycomed | Vienna | 1140 | Austria |
| Altana Pharma/Nycomed | Wiener Neustadt | 2700 | Austria |
| Altana Pharma/Nycomed | Amberg | 92224 | Germany |
| Altana Pharma/Nycomed | Aschersleben | 6449 | Germany |
| Altana Pharma/Nycomed | Berlin | 10409 | Germany |
| Altana Pharma/Nycomed | Berlin | 12587 | Germany |
| Altana Pharma/Nycomed | Berlin | 13581 | Germany |
| Altana Pharma/Nycomed | Cologne | 50999 | Germany |
| Altana Pharma/Nycomed | Cologne | 51065 | Germany |
| Altana Pharma/Nycomed | Freising | 85356 | Germany |
| Altana Pharma/Nycomed | Germersheim | 76726 | Germany |
| Altana Pharma/Nycomed | Grünstadt | 67269 | Germany |
| Altana Pharma/Nycomed | Jülich | 52428 | Germany |
| Altana Pharma/Nycomed | Köthen | 6366 | Germany |
| Altana Pharma/Nycomed | Künzing | 94550 | Germany |
| Altana Pharma/Nycomed | Landsberg | 6188 | Germany |
| Altana Pharma/Nycomed | Langen | 63225 | Germany |
| Altana Pharma/Nycomed | Leipzig | 4105 | Germany |
| Altana Pharma/Nycomed | Ludwigshafen | 67067 | Germany |
| Altana Pharma/Nycomed | Lüneburg | 21335 | Germany |
| Altana Pharma/Nycomed | Mönchengladbach | 41239 | Germany |
| Altana Pharma/Nycomed | München | 80639 | Germany |
| Altana Pharma/Nycomed | Potsdam-Babelsberg | 14482 | Germany |
| Altana Pharma/Nycomed | Reinfeld | 23858 | Germany |
| Altana Pharma/Nycomed | Saarbrücken | 66111 | Germany |
| Altana Pharma/Nycomed | Budapest | 1125 | Hungary |
| Altana Pharma/Nycomed | Győr | 9024 | Hungary |
| Altana Pharma/Nycomed | Hatvan | 3000 | Hungary |
| Altana Pharma/Nycomed | Kaposvár | 7400 | Hungary |
| Altana Pharma/Nycomed | Kistarcsa | 2143 | Hungary |
| Altana Pharma/Nycomed | Miskolc | 3526 | Hungary |
| Altana Pharma/Nycomed | Szentes | 6600 | Hungary |
| Altana Pharma/Nycomed | Vác | 2601 | Hungary |
| 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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