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

NCT ID: NCT00206050

Last Updated: 2011-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2004-12-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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Esomeprazole

Intervention Type DRUG

pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Locations

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Research Site

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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D9612L00066

Identifier Type: -

Identifier Source: org_study_id

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