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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda México S.A. de C.V. )
ClinicalTrials.gov Identifier:
NCT01499693
First received: September 12, 2011
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Gastric pH Control
 Drug: Magnesium Pantoprazole 20 mg
Drug: Magnesium Pantoprazole 40 mg
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 NLM:

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • Vital signs, physical exploration and common laboratory tests (if required). [ Time Frame: Day 0 (baseline) and day 6 of each treatment period. ] [ Designated as safety issue: Yes ]
    Safety will be established by monitoring these clinical criteria


Enrollment: 0
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499693

Locations
Mexico
Hospital Español de Mexico
Mexico City, Mexico, 11850
Sponsors and Collaborators
Takeda México S.A. de C.V.
Investigators
Principal Investigator: Edgardo Suarez, MD, MSc Clinic at Hospital Español de Mexico
Study Director: Jose A Vargas, MD, MSc Takeda Global Research & Development Center, Inc.
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Takeda México S.A. de C.V. )
ClinicalTrials.gov Identifier: NCT01499693     History of Changes
Other Study ID Numbers: MX026, U1111-1132-3320
Study First Received: September 12, 2011
Last Updated: September 14, 2012
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Takeda Global Research & Development Center, Inc.:
Proton Pump Inhibitors
gastric pH

Additional relevant MeSH terms:
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013