Status:
WITHDRAWN
Magnesium Pantoprazole 20mg b.i.d. vs Magnesium Pantoprazole 40mg q.d. on Intragastric Acid Inhibition
Lead Sponsor:
Takeda
Conditions:
Gastric pH Control
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 pantopra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01499693
Last Update
September 17 2012
Active Locations (1)
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1
Hospital Español de Mexico
Mexico City, Mexico City, Mexico, 11850