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
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
1 other identifier
interventional
40
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 healthy
Started Sep 2004
Shorter than P25 for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedJanuary 21, 2011
January 1, 2011
3 months
September 12, 2005
January 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The percent time of intragastric pH>4.0 on oral dosing Day 5 during the 24-hour intragastric pH monitoring period.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Oklahoma City, Oklahoma, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 21, 2005
Study Start
September 1, 2004
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
January 21, 2011
Record last verified: 2011-01