Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
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|ClinicalTrials.gov Identifier: NCT01077076|
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : April 2, 2010
Last Update Posted : March 11, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Intragastric Acidity||Drug: Zegerid Drug: Prilosec OTC™ Tablets Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
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.
- 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