The purpose of this study is to investigate the efficacy of lansoprazole combination with domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).
Objectives of the trial to assess the efficacy of lansoprazole in combination with domperidone on gastric acidity, intraesophageal acidity, GERD symptoms, impedance kinetics and gastric emptying in patients with GERD. 24 hour pH measurement and gastric emptying test will be done at screening visit and after 7 days of drug treatment. Twelve patients will take one tablet for 7 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
DUOLANS 30/30 mg SR tablet per oral, one tablet daily
Department Of Gastroenterology, Faculty Of Medicine, Ege University, Izmir, Turkey
Izmir, Turkey (Türkiye)
The percentage time of 24-hour intragastric pH >4 compared to baseline
Time frame: 7 days
The AUC of 24-hour intragastric pH >4 compared to baseline
Time frame: 7 days
The significant increase in total measurements of median pH
Time frame: 7 days
The significant increase in nocturnal measurements of median pH
Time frame: 7 days
The decrease in reflux symptom index calculated by weekly regurgitation numbers
Time frame: 7 days
The decrease in reflux symptom index calculated by weekly pyrosis numbers
Time frame: 7 days
The percentage time of 24-hour intragastric pH >2 compared to baseline
Time frame: 7 days
The percentage time of 24-hour intragastric pH >6 compared to baseline
Time frame: 7 days
The AUC of 24-hour intragastric pH >2 compared to baseline
Time frame: 7 days
The AUC of 24-hour intragastric pH >6 compared to baseline
Time frame: 7 days
The percentage time of 24-hour total intragastric pH >4 compared to baseline
Time frame: 7 days
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The AUC of 24-hour total intragastric pH >4 compared to baseline
Time frame: 7 days
The evaluation of gastric emptying by octanoic acid breath test compared to baseline
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 Treatment)
Time frame: 7 days