Study of 24-Hour Intragastric pH Profiles of Esomeprazole 40 Mg and Lansoprazole 30 Mg in Healthy Volunteer Subjects
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Nexium (Drug); Prevacid (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Nexium Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Summary
This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers
better intragastric acid suppression than iv lansoprazole (Prevacid ®
Clinical Details
Official title: 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
Study design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: 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 outcome: Secondary Outcomes will compare additional efficacy and safety parameters.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Research Site, Los Angeles, California, United States
Research Site, Oklahoma City, Oklahoma, United States
Additional Information
Starting date: August 2005
Last updated: June 21, 2006
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