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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Esomeprazole
Lansoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014