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

NCT ID: NCT01499693

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

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.

Conditions

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Gastric pH Control

Keywords

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Proton Pump Inhibitors gastric pH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Magnesium Pantoprazole 20mg

Group Type EXPERIMENTAL

Magnesium Pantoprazole 20 mg

Intervention Type DRUG

oral dose, twice a day

Magnesium Pantoprazole 40mg

Group Type ACTIVE_COMPARATOR

Magnesium Pantoprazole 40 mg

Intervention Type DRUG

oral dose, once a day (morning)

Placebo

Intervention Type DRUG

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).

Interventions

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Magnesium Pantoprazole 20 mg

oral dose, twice a day

Intervention Type DRUG

Magnesium Pantoprazole 40 mg

oral dose, once a day (morning)

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Tecta 20 Tecta 40

Eligibility Criteria

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Inclusion Criteria

* Carlsson-Dent Questionnaire with score ≤ 4 (negative for GERD).
* Endoscopy: negative for GERD
* BMI between 18.5 and 30

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edgardo Suarez, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Clinic at Hospital Español de Mexico

Jose A Vargas, MD, MSc

Role: STUDY_DIRECTOR

Takeda

Locations

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Hospital Español de Mexico

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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U1111-1132-3320

Identifier Type: REGISTRY

Identifier Source: secondary_id

MX026

Identifier Type: -

Identifier Source: org_study_id