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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01499693
Recruitment Status : Withdrawn
First Posted : December 26, 2011
Last Update Posted : September 17, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Gastric pH Control Drug: Magnesium Pantoprazole 20 mg Drug: Magnesium Pantoprazole 40 mg Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Magnesium Pantoprazole 20mg Drug: Magnesium Pantoprazole 20 mg
oral dose, twice a day
Other Name: Tecta 20
Active Comparator: Magnesium Pantoprazole 40mg Drug: Magnesium Pantoprazole 40 mg
oral dose, once a day (morning)
Other Name: 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).

Primary Outcome Measures :
  1. Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry. [ Time Frame: 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 :
  1. Vital signs, physical exploration and common laboratory tests (if required). [ Time Frame: Day 0 (baseline) and day 6 of each treatment period. ]
    Safety will be established by monitoring these clinical criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01499693

Hospital Español de Mexico
Mexico City, Mexico, 11850
Sponsors and Collaborators
Principal Investigator: Edgardo Suarez, MD, MSc Clinic at Hospital Español de Mexico
Study Director: Jose A Vargas, MD, MSc Takeda

Responsible Party: Takeda Identifier: NCT01499693     History of Changes
Other Study ID Numbers: MX026
U1111-1132-3320 ( Registry Identifier: WHO )
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by Takeda:
Proton Pump Inhibitors
gastric pH

Additional relevant MeSH terms:
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action