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Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting symptoms related to gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.
When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning sensation in the chest or throat. This sensation is often referred to as heartburn. Some patients have symptoms of GERD without visible destruction of the tissue surface (no visible changes by endoscopic examination).
The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in the morning. Endoscopy will be performed at the start of the study, and then as required after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of pantoprazole.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing. |
| Measure | Description | Time Frame |
|---|---|---|
| complete reflux disease remission rates after 4, 8, and 12 weeks | ||
| time to reach first complete remission | ||
| time to reach sustained complete remission |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hartmut Heinze, MD | Altana Pharma AG, D-78467 Konstanz, Germany, info.clintrials@altanapharma.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana Pharma/Nycomed | Deutschlandsberg | 8539 | Austria | |||
| Altana Pharma/Nycomed |
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| time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire |
| average symptom load above pre-defined GERD symptoms threshold |
| relief rates from reflux disease related complaints after 4, 8 and 12 weeks |
| endoscopically confirmed healing rates after 4, 8, and 12 weeks |
| symptom relief rates after 4, 8 and 12 weeks |
| influence of the H. pylori status on the complete reflux disease remission rate |
| influence of the H. pylori status on the symptom relief rates |
| influence of the H. pylori status on the endoscopically confirmed healing rates. |
| Feldbach |
| 8330 |
| Austria |
| Altana Pharma/Nycomed | Graz | 8010 | Austria |
| Altana Pharma/Nycomed | Graz | 8020 | Austria |
| Altana Pharma/Nycomed | Krems A. D. Donau | 3500 | Austria |
| Altana Pharma/Nycomed | Lilienfeld | 3180 | Austria |
| Altana Pharma/Nycomed | Stockerau | 2000 | Austria |
| Altana Pharma/Nycomed | Vienna | 1130 | Austria |
| Altana Pharma/Nycomed | Vienna | 1140 | Austria |
| Altana Pharma/Nycomed | Vienna | 1170 | Austria |
| Altana Pharma/Nycomed | Wiener Neustadt | 2700 | Austria |
| Altana Pharma/Nycomed | Amberg | 92224 | Germany |
| Altana Pharma/Nycomed | Aschersleben | 6449 | Germany |
| Altana Pharma/Nycomed | Bad Bramstedt | 24576 | Germany |
| Altana Pharma/Nycomed | Bad Schwalbach | 65307 | Germany |
| Altana Pharma/Nycomed | Beckum | 59269 | Germany |
| Altana Pharma/Nycomed | Berlin | 10409 | Germany |
| Altana Pharma/Nycomed | Berlin | 12587 | Germany |
| Altana Pharma/Nycomed | Berlin | 13581 | Germany |
| Altana Pharma/Nycomed | Flensburg | 24937 | Germany |
| Altana Pharma/Nycomed | Freiburg im Breisgau | 79098 | Germany |
| Altana Pharma/Nycomed | Freising | 85356 | Germany |
| Altana Pharma/Nycomed | Germersheim | 76726 | Germany |
| Altana Pharma/Nycomed | Hamburg | 22335 | Germany |
| Altana Pharma/Nycomed | Haßfurt | 97437 | Germany |
| Altana Pharma/Nycomed | Herzogenrath | 52134 | Germany |
| Altana Pharma/Nycomed | Jülich | 52428 | Germany |
| Altana Pharma/Nycomed | Kirchheimbolanden | 67292 | Germany |
| Altana Pharma/Nycomed | Landsberg | 6188 | Germany |
| Altana Pharma/Nycomed | Langen | 63225 | Germany |
| Altana Pharma/Nycomed | Leipzig | 4105 | Germany |
| Altana Pharma/Nycomed | Ludwigsburg | 71640 | Germany |
| Altana Pharma/Nycomed | Ludwigshafen | 67067 | Germany |
| Altana Pharma/Nycomed | Lübeck | 23569 | Germany |
| Altana Pharma/Nycomed | Lütjenburg | 24321 | Germany |
| Altana Pharma/Nycomed | Magdeburg | 39114 | Germany |
| Altana Pharma/Nycomed | Magdeburg | 39130 | Germany |
| Altana Pharma/Nycomed | Mönchengladbach | 41239 | Germany |
| Altana Pharma/Nycomed | München | 80337 | Germany |
| Altana Pharma/Nycomed | München | 81669 | Germany |
| Altana Pharma/Nycomed | Nieder-Olm | 55268 | Germany |
| Altana Pharma/Nycomed | Oelde | 59302 | Germany |
| Altana Pharma/Nycomed | Potsdam-Babelsberg | 14482 | Germany |
| Altana Pharma/Nycomed | Reinfeld | 23858 | Germany |
| Altana Pharma/Nycomed | Rottweil | 78628 | Germany |
| Altana Pharma/Nycomed | Saarbrücken | 66111 | Germany |
| Altana Pharma/Nycomed | Schweinfurt | 97421 | Germany |
| Altana Pharma/Nycomed | Stuttgart | 70565 | Germany |
| Altana Pharma/Nycomed | Tessin | 18195 | Germany |
| Altana Pharma/Nycomed | Wiesbaden | 65189 | Germany |
| Altana Pharma/Nycomed | Wolfsburg | 38448 | Germany |
| Altana Pharma/Nycomed | Wolmirstedt | 39326 | Germany |
| Altana Pharma/Nycomed | Budapest | 1032 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1062 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1085 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1115 | Hungary |
| Altana Pharma/Nycomed | Győr | 9024 | Hungary |
| Altana Pharma/Nycomed | Gyula | 5700 | Hungary |
| Altana Pharma/Nycomed | Hatvan | 3000 | Hungary |
| Altana Pharma/Nycomed | Kaposvár | 7400 | Hungary |
| Altana Pharma/Nycomed | Miskolc | 3526 | Hungary |
| Altana Pharma/Nycomed | Pécs | 7632 | Hungary |
| Altana Pharma/Nycomed | Szeged | 6720 | Hungary |
| Altana Pharma/Nycomed | Szekszárd | 7100 | Hungary |
| Altana Pharma/Nycomed | Szentes | 6600 | Hungary |
| Altana Pharma/Nycomed | Székesfehérvár | 8000 | Hungary |
| Altana Pharma/Nycomed | Szombathely | 9701 | Hungary |
| Altana Pharma/Nycomed | Tatabánya | 2800 | Hungary |
| Altana Pharma/Nycomed | Vác | 2601 | Hungary |
| Altana Pharma/Nycomed | Bydgoszcz | 85-168 | Poland |
| Altana Pharma/Nycomed | Drezdenko | 66-530 | Poland |
| Altana Pharma/Nycomed | Kielce | 25-513 | Poland |
| Altana Pharma/Nycomed | Krakow | 31-153 | Poland |
| Altana Pharma/Nycomed | Rzeszów | 35-068 | Poland |
| Altana Pharma/Nycomed | Rzeszów | 35025 | Poland |
| Altana Pharma/Nycomed | Sopot | 81-756 | Poland |
| Altana Pharma/Nycomed | Słupsk | 76200 | Poland |
| Altana Pharma/Nycomed | Torun | 87-100 | Poland |
| Altana Pharma/Nycomed | Tychy | 43-100 | Poland |
| 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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