Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects

Phase 4

Completed

• Conditions: Healthy

• Registration Number: NCT00230516
• Lead Sponsor: AstraZeneca

Brief Summary

This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers better intragastric acid suppression than iv lansoprazole (Prevacid ®

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-28
• Study First Submitted QC: 2005-09-29
• Study First Posted: 2005-10-03
• Study Completion: 2006-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Secondary Outcomes will compare additional efficacy and safety parameters.

Trial Locations

Locations (1)

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