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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
628
Symptom Assessment after treatment with Pantoprozole 40 mg
Altana Pharma/Nycomed
Bondi Junction, Australia
Altana Pharma/Nycomed
Box Hill, Victoria, Australia
Altana Pharma/Nycomed
New South Wales, Australia
Altana Pharma/Nycomed
South Australia, Australia
Altana Pharma/Nycomed
Feldbach, Austria
Altana Pharma/Nycomed
symptom assessment as measured by ReQuest™ questionnaire and investigator.
Time frame: 28 days
symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator
Time frame: 28 days
endoscopic healing after 28 days
Time frame: 28 days
health-related quality of life after 28 days
Time frame: 28 days
safety.
Time frame: 28 days
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Graz, Austria
Altana Pharma/Nycomed
Stockerau, Austria
Altana Pharma/Nycomed
Vienna, Austria
Altana Pharma/Nycomed
Wiener Neustadt, Austria
Altana Pharma/Nycomed
Amberg, Germany
...and 30 more locations