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Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial.
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The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. | Active Comparator | 40 mg Pantoprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | 40 mg Pantoprazole |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-gastrointestinal (GI) questionnaire | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-GI questionnaire | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Oudkerk Pool, Prof. | Isala Klieniken, Zwolle, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana Pharma/Nycomed | BT Oss | 5342 | Netherlands | |||
| Altana Pharma/Nycomed |
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| Den Helder |
| 1782 GZ |
| Netherlands |
| Altana Pharma/Nycomed | EH Geldrop | 5664 | Netherlands |
| Altana Pharma/Nycomed | Basel | 4001 | Switzerland |
| Altana Pharma/Nycomed | Basel | 4051 | Switzerland |
| Altana Pharma/Nycomed | Biel/Bienne | 2502 | Switzerland |
| Altana Pharma/Nycomed | Bülach | 8180 | Switzerland |
| Altana Pharma/Nycomed | Locarno, TI. | 6600 | Switzerland |
| Altana Pharma/Nycomed | Lucerne | 6003 | Switzerland |
| Altana Pharma/Nycomed | Lucerne | 6004 | Switzerland |
| Altana Pharma/Nycomed | Reinach | 4153 | Switzerland |
| Altana Pharma/Nycomed | Sion | 1950 | Switzerland |
| Altana Pharma/Nycomed | Thun | 3600 | Switzerland |
| Altana Pharma/Nycomed | Winterthur | 8400 | Switzerland |
| Altana Pharma/Nycomed | Zurich | 8050 | Switzerland |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D000096663 | Non-Erosive Reflux Disease |
| 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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