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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Acid; Human Experimentation

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

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: May 2008
Last updated: February 20, 2015

Page last updated: August 23, 2015

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