Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to:
- provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments;
- compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.
- evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
|Intragastric Acidity||Drug: Zegerid Drug: Prilosec OTC™ Tablets Other: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|Official Title:||Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole|
- Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment [ Time Frame: 4 hours after dose on Day 4 ]Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments
|Study Start Date:||December 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Zegerid OTC Capsules
20 mg omeprazole and 1100 mg sodium bicarbonate
Zegerid taken once daily for 11 days.
Active Comparator: Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole
20.6 mg omeprazole-magnesium complex.
Drug: Prilosec OTC™ Tablets
Prilosec OTC™ Tablets taken once daily for 11 days.
Placebo Comparator: Placebo
Placebo taken once daily for 11 days.