NCT00230516CompletedPhase 4
A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects on Days 1 and 5 of Intravenous Treatment
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- The primary objective is to compare the pharmacodynamic efficacy in controlling intragastric pH of esomeprazole 40mg and lansoprazole 30mg on Day 5 of once daily IV administration to healthy volunteers.
Study Overview
Brief Summary
This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers better intragastric acid suppression than iv lansoprazole (Prevacid ®
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants must be 18-70 years of age
- •Participants can be male or female
- •Women that are able to have children must have a negative pregnancy test.
Exclusion Criteria
- •Involvement in or planning of this study
- •Participation in another clinical study within 28 days of this one
- •For women, pregnancy or attempting to become pregnant.
Outcomes
Primary Outcomes
The primary objective is to compare the pharmacodynamic efficacy in controlling intragastric pH of esomeprazole 40mg and lansoprazole 30mg on Day 5 of once daily IV administration to healthy volunteers.
Secondary Outcomes
- Secondary Outcomes will compare additional efficacy and safety parameters.
Investigators
Study Sites (2)
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