A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)

Study Overview
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Brief Summary
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Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.

Detailed Description
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Enrolled participants were divided into 2 groups, with 30 participants in each group. Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions. Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on the days which they received their 1st and last (7th) dose of the two treatment drugs. In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.

Official Title
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Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)

Conditions
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Gastric Acid, Human Experimentation

Intervention / Treatment
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* Drug: Omeprazole/sodium bicarbonate
* Drug: omeprazole magnesium (20 mg equivalent)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal subjects who are 18-65 years of age. Non-childbearing potential females or those using birth control. Exclusion Criteria: History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors History of significant gastrointestinal disease Any significant medical illness Gastrointestinal disorder or surgery leading to impaired drug absorption Currently using gastrointestinal medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zegerid<br>Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule | Drug: Omeprazole/sodium bicarbonate<br>* Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.<br>* Other names: Zegerid;|
| Active Comparator: Prilosec<br>Omeprazole magnesium 20 mg OTC tablet | Drug: omeprazole magnesium (20 mg equivalent)<br>* Single dose of omeprazole magnesium per day for either 1 or 7 days.<br>* Other names: Prilosec OTC Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. | Baseline and 7 days |