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

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastric pH Control
• Intervention / Treatment: Drug: Magnesium Pantoprazole 20 mg; Drug: Magnesium Pantoprazole 40 mg; Drug: Placebo

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 11850
    • Hospital Español de Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnesium Pantoprazole 20mg	Drug: Magnesium Pantoprazole 20 mg; oral dose, twice a day; Other Names: Tecta 20
Active Comparator: Magnesium Pantoprazole 40mg	Drug: Magnesium Pantoprazole 40 mg; oral dose, once a day (morning); Other Names: Tecta 40; 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).

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Principal Investigator: Edgardo Suarez, MD, MSc, Clinic at Hospital Español de Mexico; Study Director: Jose A Vargas, MD, MSc, Takeda

Study record dates

Study Registration Dates

• First Submitted: September 12, 2011
• First Submitted That Met QC Criteria: December 23, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): September 17, 2012
• Last Update Submitted That Met QC Criteria: September 14, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Proton Pump Inhibitors; gastric pH
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: MX026; U1111-1132-3320 (Registry Identifier: WHO)