A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)
Abstract
The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
Conditions: Gastroesophageal Reflux Disease.
Primary outcome: Mean Change From Baseline to Month 12 for Hemoglobin Values; Mean Change From Baseline to Month 12 for Hematocrit Values; Mean Change From Baseline to Month 12 for Red Blood Cell Count Values; Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values; Mean Change From Baseline to Month 12 for Platelet Count Values; Mean Change From Baseline to Month 12 for White Blood Cell Count Values; Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values; Mean Change From Baseline to Month 12 for Creatinine Values; Mean Change From Baseline to Month 12 for Calcium Values; Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values; Mean Change From Baseline to Month 12 for Total Bilirubin Values; Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values; Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values; Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values; Mean Change From Baseline to Month 12 for Serum Gastrin Levels; Mean Change From Baseline to Month 12 for Systolic Blood Pressure; Mean Change From Baseline to Month 12 for Diastolic Blood Pressure; Mean Change From Baseline to Month 12 for Pulse Rate; Changes From Baseline to Final Visit in Antrum…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 591 participants or records.
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