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

Phase 3

Withdrawn

• Conditions: Gastric pH Control
• Interventions: Drug: Magnesium Pantoprazole 20 mg; Drug: Magnesium Pantoprazole 40 mg; Drug: Placebo

• Registration Number: NCT01499693
• Lead Sponsor: Takeda

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-09-12
• Study First Submitted QC: 2011-12-23
• Study First Posted: 2011-12-26
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Magnesium Pantoprazole 20mg	Magnesium Pantoprazole 20 mg	-
Magnesium Pantoprazole 40mg	Magnesium Pantoprazole 40 mg	-
Magnesium Pantoprazole 40mg	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry.	Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Español de Mexico; 🇲🇽 Mexico City, Mexico