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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00230516
First received: September 28, 2005
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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:

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: September 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

ClinicalTrials.gov Identifier: NCT00230516     History of Changes
Other Study ID Numbers: D9612L00080
Study First Received: September 28, 2005
Last Updated: January 3, 2013
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:
Omeprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 18, 2013