Magnesium Pantoprazole 20mg b.i.d. vs Magnesium Pantoprazole 40mg q.d. on Intragastric Acid Inhibition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Gastric pH Control

Intervention / Treatment
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* Drug: Magnesium Pantoprazole 20 mg
* Drug: Magnesium Pantoprazole 40 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Main inclusion criteria: Carlsson-Dent Questionnaire with score ≤ 4 (negative for GERD). Endoscopy: negative for GERD BMI between 18.5 and 30 Main exclusion criteria: Volunteers with any the following symptoms: dysphagia, digestive track bleeding, anorexia, anemia, involuntary weight loss. Women under breastfeeding period, pregnant or under pregnancy suspicion. Subjects with abnormal manometry (any motor esophageal disorder). Peptic ulcer history and/or ulcer complication. Volunteers under PPI treatment, H. pylori eradication treatment, H2 receptor antagonists, prokinetics or similar medication (current, during the last 30 days or during the trial). History of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAID) use, during the last 30 days. Abnormal laboratory parameters or vital signs, considered clinically relevant by the researcher.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium Pantoprazole 20mg<br> | Drug: Magnesium Pantoprazole 20 mg<br>* oral dose, twice a day<br>* Other names: Tecta 20;|
| Active Comparator: Magnesium Pantoprazole 40mg<br> | Drug: Magnesium Pantoprazole 40 mg<br>* oral dose, once a day (morning)<br>* Other names: Tecta 40;Drug: Placebo<br>* oral dose, once a day (night) Placebo will be administered at night in the group with 40mg magnesium pantoprazole to keep the blinding (so treatment administration is comparable w/the 20mg group).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry. | Electrode will be placed in the gastric lumen, 10 cm below the lower esophageal sphincter. The percentage of time with pH >4.0 between both treatments will be compared. | Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs, physical exploration and common laboratory tests (if required). | Safety will be established by monitoring these clinical criteria | Day 0 (baseline) and day 6 of each treatment period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton Pump Inhibitors, gastric pH