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Sponsors and Collaborators: |
Schering-Plough Santarus |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00674115 |
Open-label randomized crossover design studies. 60 subjects will be evaluated on Day 1 to compare effects on stomach acid; 30 subjects will continue treatment for 7 days and will have repeat evaluations at Day 7.
Condition | Intervention | Phase |
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Gastric Acid Human Experimentation |
Drug: Omeprazole/sodium bicarbonate Drug: omeprazole magnesium Drug: sodium bicarbonate |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 mg-Equivalent Omeprazole) |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single Dose Zegerid for 1 or 7 days: Experimental
Omeprazole /sodium bicarbonate
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Drug: Omeprazole/sodium bicarbonate
Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
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Single Dose Prilosec OTC Tablet for 1 or 7 days: Active Comparator
omeprazole magnesium
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Drug: omeprazole magnesium
Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
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sodium bicarbonate: Active Comparator
Sodium bicarbonate
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Drug: sodium bicarbonate
Sodium bicarbonate. Single dose.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | CL2007-17 |
Study First Received: | May 2, 2008 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00674115 |
Health Authority: | United States: Food and Drug Administration |
Omeprazole |
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