Gastric pH Control
Conditions
Keywords
Proton Pump Inhibitors, gastric pH
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.
Interventions
DRUGMagnesium Pantoprazole 20 mg
oral dose, twice a day
DRUGMagnesium Pantoprazole 40 mg
oral dose, once a day (morning)
DRUGPlacebo
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).
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry. | 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
| Measure | Time frame | Description |
|---|---|---|
| Vital signs, physical exploration and common laboratory tests (if required). | Day 0 (baseline) and day 6 of each treatment period. | Safety will be established by monitoring these clinical criteria |
Countries
Mexico
Outcome results
None listed