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.

First Received: September 12, 2005 Last Updated: March 25, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206050

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 IV

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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:

Drug Information available for: Omeprazole Omeprazole magnesium Pantoprazole Pantoprazole Sodium Esomeprazole Sodium Esomeprazole magnesium

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:	October 2004

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

Study ID Numbers:	D9612L00066
Study First Received:	September 12, 2005
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00206050 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Pantoprazole
Anti-Ulcer Agents

Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010