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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.
Information provided by:
AstraZeneca Identifier:
First received: September 12, 2005
Last updated: January 20, 2011
Last verified: January 2011
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
Intervention Model: Crossover Assignment
Masking: None (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:

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)

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00206050

United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators
  More Information Identifier: NCT00206050     History of Changes
Other Study ID Numbers: D9612L00066
Study First Received: September 12, 2005
Last Updated: January 20, 2011

Additional relevant MeSH terms:
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017