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

This study has been completed.

First Received: September 28, 2005 Last Updated: March 25, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00230516

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Nexium Drug: Prevacid	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
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

Resource links provided by NLM:

Drug Information available for: Omeprazole Omeprazole magnesium Lansoprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

Secondary Outcomes will compare additional efficacy and safety parameters.

Estimated Enrollment:	100
Study Start Date:	August 2005
Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230516

Locations

United States, California
Research Site
Los Angeles, California, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Nexium Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D9612L00080
Study First Received:	September 28, 2005
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00230516 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

N/A this study is being conducted with healthy volunteers

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents

Omeprazole
Enzyme Inhibitors
Lansoprazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010