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

NCT01499693 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-09-17

No results posted yet for this study

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.

Conditions

  • Gastric pH Control

Interventions

DRUG

Magnesium Pantoprazole 20 mg

oral dose, twice a day

DRUG

Magnesium Pantoprazole 40 mg

oral dose, once a day (morning)

DRUG

Placebo

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).

Sponsors & Collaborators

Principal Investigators

  • Edgardo Suarez, MD, MSc · Clinic at Hospital Español de Mexico

  • Jose A Vargas, MD, MSc · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01499693 on ClinicalTrials.gov