It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in patients with Gastroesophageal Reflux Disease (GERD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Rabelis DDR 50 mg Capsules once daily for seven days.
Pariet 20 mg Enteric Coated Tablets once daily for seven days.
Ege University Facult of Medicine Gastroenterology Department
Izmir, Turkey (Türkiye)
Percentage time of 24-hour intragastric pH >4 compared to baseline
Time frame: 7 days
AUC of 24-hour intragastric pH >4 compared to baseline
Time frame: 7 days
Significant increase in total measurements of median pH
Time frame: 7 days
Significant increase in nocturnal measurements of median pH
Time frame: 7 days
Decrease in reflux symptom index calculated by weekly regurgitation numbers
Time frame: 7 days
Decrease in reflux symptom index calculated by weekly pyrosis numbers
Time frame: 7 days
Percentage time of 24-hour intragastric pH >2 compared to baseline
Time frame: 7 days
Percentage time of 24-hour intragastric pH >6 compared to baseline
Time frame: 7 days
AUC of 24-hour intragastric pH >2 compared to baseline
Time frame: 7 days
AUC of 24-hour intragastric pH >6 compared to baseline
Time frame: 7 days
Percentage time of 24-hour total intragastric pH >4 compared to baseline
Time frame: 7 days
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AUC of 24-hour total intragastric pH >4 compared to baseline
Time frame: 7 days
Percentage time of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline baseline
rate of night reflux
Time frame: 7 days
AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline
rate of night reflux
Time frame: 7 days
The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatments)
Time frame: 7 days
Change in QT interval obtained by ECG compared to baseline
Time frame: 21 days