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The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| further efficacy criteria | ||
| safety |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner Janssen, MD | 23569 Lübeck, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana Pharma/Nycomed | Belo Horizonte-MG | 30150270 | Brazil | |||
| Altana Pharma/Nycomed |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24083350 | Derived | Monnikes H, Schwan T, van Rensburg C, Straszak A, Theek C, Luhmann R, Sander P, Tholen A. Possible etiology of improvements in both quality of life and overlapping gastroesophageal reflux disease by proton pump inhibitor treatment in a prospective randomized controlled trial. BMC Gastroenterol. 2013 Oct 1;13:145. doi: 10.1186/1471-230X-13-145. |
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| Blumenau - SC |
| 89010906 |
| Brazil |
| Altana Pharma/Nycomed | Botucatu - SP | 18610970 | Brazil |
| Altana Pharma/Nycomed | Campinas - Sao Paulo | 13070040 | Brazil |
| Altana Pharma/Nycomed | Campinas - SP | 13013101 | Brazil |
| Altana Pharma/Nycomed | Curitiba - PR | 80060 | Brazil |
| Altana Pharma/Nycomed | Ilha Do Fundao - Rio de Janeiro - RJ | 21941590 | Brazil |
| Altana Pharma/Nycomed | Pinheiros Sao Paulo - SP | 1246-000 | Brazil |
| Altana Pharma/Nycomed | Porto Alegre - RS | 90035003 | Brazil |
| Altana Pharma/Nycomed | Porto Alegre-RS | 90020090 | Brazil |
| Altana Pharma/Nycomed | Porto Alegre-RS | 90610000 | Brazil |
| Altana Pharma/Nycomed | Ribeirao Preto-SP | 14048900 | Brazil |
| Altana Pharma/Nycomed | Salvador-BA | 41256900 | Brazil |
| Altana Pharma/Nycomed | São Paulo | 4024002 | Brazil |
| Altana Pharma/Nycomed | Bad Schwalbach | 65307 | Germany |
| Altana Pharma/Nycomed | Burg | 39288 | Germany |
| Altana Pharma/Nycomed | Gardelegen | 39638 | Germany |
| Altana Pharma/Nycomed | Königstein | 61462 | Germany |
| Altana Pharma/Nycomed | Lübeck | 23569 | Germany |
| Altana Pharma/Nycomed | Lüdenscheid | 58507 | Germany |
| Altana Pharma/Nycomed | Lütjenburg | 24321 | Germany |
| Altana Pharma/Nycomed | Nieder-Olm | 55268 | Germany |
| Altana Pharma/Nycomed | Oelde | 59302 | Germany |
| Altana Pharma/Nycomed | Wiesbaden | 65189 | Germany |
| Altana Pharma/Nycomed | Wolmirstedt | 39326 | Germany |
| Altana Pharma/Nycomed | Bydgoszcz | 85-681 | Poland |
| Altana Pharma/Nycomed | Inowrocław | 88-100 | Poland |
| Altana Pharma/Nycomed | Poznan | 60479 | Poland |
| Altana Pharma/Nycomed | Siemianowice Śląskie | 41-100 | Poland |
| Altana Pharma/Nycomed | Torun | 87-100 | Poland |
| Altana Pharma/Nycomed | Tychy | 43-100 | Poland |
| Altana Pharma/Nycomed | Berea, Durban | 4000 | South Africa |
| Altana Pharma/Nycomed | Bloemfontein | 9301 | South Africa |
| Altana Pharma/Nycomed | Bloemfontein | 9317 | South Africa |
| Altana Pharma/Nycomed | Cape Town | 7530 | South Africa |
| Altana Pharma/Nycomed | Durban | 4001 | South Africa |
| Altana Pharma/Nycomed | eManzimtoti | 4126 | South Africa |
| Altana Pharma/Nycomed | Goodwood | 7460 | South Africa |
| Altana Pharma/Nycomed | Johannesburg | 2033 | South Africa |
| Altana Pharma/Nycomed | Overport, Durban | 4001 | South Africa |
| Altana Pharma/Nycomed | Panorama | 7500 | South Africa |
| Altana Pharma/Nycomed | Pinetown | 4013 | South Africa |
| Altana Pharma/Nycomed | Port Elizabeth | 6001 | South Africa |
| Altana Pharma/Nycomed | Pretoria | 48 | South Africa |
| Altana Pharma/Nycomed | Somerset West | 7130 | South Africa |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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