Gastric pH Control Clinical Trial
Official title:
Phase IIIb, Randomized, Triple-blinded and Crossover Study to Evaluate the Effect of Magnesium Pantoprazole 20mg Bid Versus Magnesium Pantoprazole 40mg qd on Intragastric Acid Inhibition Assessed by pHmetry, in Healthy Volunteers
The purpose of this study is to determine if magnesium pantoprazole 20 mg twice a day (b.i.d.), maintains gastric pH above 4 during a longer percentage of time than magnesium pantoprazole 40 mg once a day (qd). This is a comparison between split dose concept and standard dose of proton pump inhibitors.
Eligible healthy volunteers will be randomly assigned for 2 different treatment sequences:
A) magnesium pantoprazole 20 mg b.i.d. followed by magnesium pantoprazole 40 mg q.d. or B)
magnesium pantoprazole 40 mg q.d. followed by magnesium pantoprazole 20 mg b.i.d.
Treatment sequences will be administrated as follows: 6 days with the first medication,
followed by a washout period of 8 days (no medication) and a further period of 6 days with
the second medication.
Treatment efficacy will be established by the percentage of time with intragastric pH >4,
measured by 24-hour pH-Metry on day 6 of each medication (on-treatment measurement). Basal
pH will be measured as reference.
The blinding distribution of treatments will be maintained for the patients, the doctor and
the statistician who will analyze the data.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment