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

Phase 3

Completed

• Conditions: Gastric Acid; Human Experimentation
• Interventions: Drug: Omeprazole/sodium bicarbonate; Drug: omeprazole magnesium (20 mg equivalent)

• Registration Number: NCT00765206
• Lead Sponsor: Bayer

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-02
• Results First Submitted: 2009-08-28
• Results First Submitted QC: 2010-04-08
• Results First Posted: 2010-04-30
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Normal subjects who are 18-65 years of age.
• Non-childbearing potential females or those using birth control.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Zegerid	Omeprazole/sodium bicarbonate	Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule
Prilosec	omeprazole magnesium (20 mg equivalent)	Omeprazole magnesium 20 mg OTC tablet

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration	Baseline and 7 days	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.