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

Tracking Information
First Received Date ^ICMJE	September 12, 2005
Last Updated Date	January 20, 2011
Start Date ^ICMJE	September 2004
Primary Completion Date	December 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 20, 2005)	The percent time of intragastric pH>4.0 on oral dosing Day 5 during the 24-hour intragastric pH monitoring period.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00206050 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 20, 2005)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: Esomeprazole Drug: pantoprazole
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	December 2004
Primary Completion Date	December 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00206050
Other Study ID Numbers ^ICMJE	D9612L00066
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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