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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00230516
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : January 4, 2013
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Nexium Drug: Prevacid Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : September 2005
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. Secondary Outcomes will compare additional efficacy and safety parameters.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230516


Locations
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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
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Study Director: Nexium Medical Science Director, MD AstraZeneca
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ClinicalTrials.gov Identifier: NCT00230516    
Other Study ID Numbers: D9612L00080
First Posted: October 3, 2005    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
N/A this study is being conducted with healthy volunteers
Additional relevant MeSH terms:
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Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action