Magnesium Pantoprazole 20mg b.i.d. vs Magnesium Pantoprazole 40mg q.d. on Intragastric Acid Inhibition
|Gastric pH Control||Drug: Magnesium Pantoprazole 20 mg Drug: Magnesium Pantoprazole 40 mg Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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|
- 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.
- 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
|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 40Drug: 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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499693
|Hospital Español de Mexico|
|Mexico City, Mexico, 11850|
|Principal Investigator:||Edgardo Suarez, MD, MSc||Clinic at Hospital Español de Mexico|
|Study Director:||Jose A Vargas, MD, MSc||Takeda|