The purpose of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive esophagitis.
Phase 2, open label, multi-center, 2-period study to compare the pharmacodynamics of IV lansoprazole 30 mg to oral lansoprazole 30 mg in subjects with erosive esophagitis (grade \>or= 2)diagnosed by endoscopy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.
Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.
Maximal Acid Output obtained 22 hours after the last dose of IV lansoprazole compared to the Maximal Acid Output obtained 22 hours after the last dose of oral lansoprazole following pentagastrin stimulation in both instances.
Time frame: Day 7 vs Day 15
Basal Acid Output obtained 21 hours after the last dose of IV lansoprazole compared with that obtained 21 hours after the last dose of oral lansoprazole.
Time frame: Day 7 vs Day 15
Maximum Acid Output and Basal Acid Output measurements obtained 21 hours and 22 hours, respectively, after the first dose of IV lansoprazole versus those obtained after the last dose of oral lansoprazole.
Time frame: Day 7 vs Day 8
Maximum Acid Output and Basal Acid Output results obtained after the first versus last dose of IV lansoprazole.
Time frame: Day 8 vs Day 15
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