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

Phase 4

Completed

• Conditions: Healthy

• Registration Number: NCT00206050
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The percent time of intragastric pH>4.0 on oral dosing Day 5 during the 24-hour intragastric pH monitoring period.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Oklahoma City, Oklahoma, United States