Study of Intragastric pH Profile After 5 Days Pantoprazole 40 Mg Iv Followed by Oral Esomeprazole 40 Mg Po or Oral Pantoprazole 40 Mg Po
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Esomeprazole (Drug); pantoprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca
Summary
This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole
(NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed
Release Tablets ), in subjects who continue to require acid-suppressive therapy following a
course of intravenous (iv) pantoprazole (PROTONIX ® I. V. for Injection).
Clinical Details
Official title: A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of the 24-Hour Intragastric pH Profile After 5 Days of Once Daily Oral Administration of Either Esomeprazole 40 Mg or Pantoprazole 40 Mg Following Once Daily Infusion of Intravenous Pantoprazole 40 Mg for 5 Days in Healthy Volunteer Subjects
Study design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: The percent time of intragastric pH>4.0 on oral dosing Day 5 during the 24-hour intragastric pH monitoring period.
Secondary outcome: The percent time of intragastric pH>4.0 on oral dosing Day 1 and the mean hourly cumulative IGA during the 24-hour intragastric pH monitoring periods (on oral dosing Days 1 and 5.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Provision of informed consent.
- Males and females aged 18 to 70 years, inclusive.
- Male or non-pregnant, nonlactating female healthy volunteer subjects. Females must be
post-menopausal, surgically sterilized, or using a medically acceptable form of birth
control, as determined by the investigator. Women of childbearing potential must agree
to continue using an acceptable form of birth control throughout the conduct of the
study.
Exclusion Criteria:
- Involvement in the planning and conduct of the study (applies to both AstraZeneca
staff or staff at the investigational site)
- Previous enrollment or randomization of treatment in the present study.
- Received an experimental drug or used an experimental device within 28 days preceeding
the screening visit.
Locations and Contacts
Research Site, Oklahoma City, Oklahoma, United States
Additional Information
Starting date: October 2004
Last updated: September 20, 2005
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