Clinical trial NCT01499693: Magnesium Pantoprazole 20mg b.i.d. vs Magnesium Pantoprazole 40mg q.d. on Intragastric Acid Inhibition
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gastric pH Control
Keywords: Proton Pump Inhibitors
gastric pH
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry.
timeFrame: Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period.
Secondary outcomes:
measure: Vital signs, physical exploration and common laboratory tests (if required).
timeFrame: Day 0 (baseline) and day 6 of each treatment period.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Español de Mexico
Study officials:
affiliation: Clinic at Hospital Español de Mexico
name: Edgardo Suarez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Takeda
name: Jose A Vargas, MD, MSc
role: STUDY_DIRECTOR
References: