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Study of Intragastric pH Profile After 5 Days Pantoprazole 40 mg iv Followed by Oral Esomeprazole 40 mg po or Oral Pantoprazole 40 mg po

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206050
First received: September 12, 2005
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  Purpose

This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed Release Tablets ), in subjects who continue to require acid-suppressive therapy following a course of intravenous (iv) pantoprazole (PROTONIX ® I.V. for Injection).


Condition Intervention Phase
Healthy
 Drug: Esomeprazole
Drug: pantoprazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of the 24-Hour Intragastric pH Profile After 5 Days of Once Daily Oral Administration of Either Esomeprazole 40 mg or Pantoprazole 40 mg Following Once Daily Infusion of Intravenous Pantoprazole 40 mg for 5 Days in Healthy Volunteer Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The percent time of intragastric pH>4.0 on oral dosing Day 5 during the 24-hour intragastric pH monitoring period.

Secondary Outcome Measures:
  • The percent time of intragastric pH>4.0 on oral dosing Day 1 and the mean hourly cumulative IGA during the 24-hour intragastric pH monitoring periods (on oral dosing Days 1 and 5.

Estimated Enrollment: 40
Study Start Date: September 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Provision of informed consent.
  • Males and females aged 18 to 70 years, inclusive.
  • Male or non-pregnant, nonlactating female healthy volunteer subjects. Females must be post-menopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.

Exclusion Criteria:

  • Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
  • Previous enrollment or randomization of treatment in the present study.
  • Received an experimental drug or used an experimental device within 28 days preceeding the screening visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206050

Locations
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00206050     History of Changes
Other Study ID Numbers: D9612L00066
Study First Received: September 12, 2005
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Omeprazole
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013