Gastroesophageal Reflux Clinical Trial
Official title:
PRISM: Determination of the Performance Characteristics of ReQuest (TradeMark) in Practice in the Stepped Down Management of GORD
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 reflux symptoms. Proton
pump inhibitors such as pantoprazole, can relieve symptoms of GERD in a large proportion of
patients.
Of particular interest in GERD is the assessment of symptom severity and quality of life,
and the response to treatment. Therefore, a questionnaire was developed to assess GERD
symptoms (`ReQuest TradeMark in Practice`). An important point to consider when using such a
questionnaire is to follow the patients´ medical response to treatment and note whether a
patient needs to change dosing, such as changing from full dose to half dose, or vice versa.
The aim of the study is to determine the value of the questionnaire (`ReQuest TradeMark in
Practice`) according to treating physicians` clinical judgment when using pantoprazole at
full and half dose. The study duration consists of a pre-treatment periods (0-2 weeks) and
two treatment period (8 weeks each). During the first treatment period, pantoprazole will be
administered once daily at full dose (40 mg). During the second treatment period,
pantoprazole will be administered once daily at half dose (20 mg). The study will provide
further data on safety and tolerability of pantoprazole.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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