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

Overview[ - collapse ][ - ]

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).
ConditionHealthy
InterventionDrug: Esomeprazole
Drug: pantoprazole
PhasePhase 4
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00206050
First ReceivedSeptember 12, 2005
Last UpdatedJanuary 20, 2011
Last verifiedJanuary 2011

Tracking Information[ + expand ][ + ]

First Received DateSeptember 12, 2005
Last Updated DateJanuary 20, 2011
Start DateSeptember 2004
Estimated Primary Completion DateDecember 2004
Current Primary Outcome MeasuresThe percent time of intragastric pH>4.0 on oral dosing Day 5 during the 24-hour intragastric pH monitoring period.
Current Secondary Outcome MeasuresThe 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.

Descriptive Information[ + expand ][ + ]

Brief TitleStudy 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 TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
ConditionHealthy
InterventionDrug: Esomeprazole
Drug: pantoprazole
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment40
Estimated Completion DateDecember 2004
Estimated Primary Completion DateDecember 2004
Eligibility 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00206050
Other Study ID NumbersD9612L00066
Has Data Monitoring CommitteeNot Provided
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsNot Provided
Investigators Not Provided
Verification DateJanuary 2011

Locations[ + expand ][ + ]

Research Site
Oklahoma City, Oklahoma, United States