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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1132-3320 | Registry Identifier | WHO |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Pantoprazole 20mg | Experimental |
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| Magnesium Pantoprazole 40mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Pantoprazole 20 mg | Drug | oral dose, twice a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry. | 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. | Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs, physical exploration and common laboratory tests (if required). | Safety will be established by monitoring these clinical criteria | Day 0 (baseline) and day 6 of each treatment period. |
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Main inclusion criteria:
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edgardo Suarez, MD, MSc | Clinic at Hospital Español de Mexico | Principal Investigator |
| Jose A Vargas, MD, MSc | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Español de Mexico | Mexico City | Mexico City | 11850 | Mexico |
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| Magnesium Pantoprazole 40 mg | Drug | oral dose, once a day (morning) |
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| Placebo | Drug | 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). |
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