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). |
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Condition | Healthy |
Intervention | Drug: Esomeprazole Drug: pantoprazole |
Phase | Phase 4 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT00206050 |
First Received | September 12, 2005 |
Last Updated | January 20, 2011 |
Last verified | January 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | September 12, 2005 |
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Last Updated Date | January 20, 2011 |
Start Date | September 2004 |
Estimated Primary Completion Date | December 2004 |
Current Primary Outcome Measures | The percent time of intragastric pH>4.0 on oral dosing Day 5 during the 24-hour intragastric pH monitoring period. |
Current 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. |
Descriptive Information[ + expand ][ + ]
Brief Title | 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 |
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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 |
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 | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label |
Condition | Healthy |
Intervention | Drug: Esomeprazole Drug: pantoprazole |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 40 |
Estimated Completion Date | December 2004 |
Estimated Primary Completion Date | December 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00206050 |
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Other Study ID Numbers | D9612L00066 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | January 2011 |
Locations[ + expand ][ + ]
Research Site | Oklahoma City, Oklahoma, United States |
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