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

NCT ID: NCT00765206

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-08-31

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.

Conditions

Gastric Acid; Human Experimentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Zegerid

Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule

Group Type: EXPERIMENTAL

Omeprazole/sodium bicarbonate

Intervention Type: DRUG

Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.

Prilosec

Omeprazole magnesium 20 mg OTC tablet

Group Type: ACTIVE_COMPARATOR

omeprazole magnesium (20 mg equivalent)

Intervention Type: DRUG

Single dose of omeprazole magnesium per day for either 1 or 7 days.

Interventions

Omeprazole/sodium bicarbonate

Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.

Intervention Type: DRUG

omeprazole magnesium (20 mg equivalent)

Single dose of omeprazole magnesium per day for either 1 or 7 days.

Intervention Type: DRUG

Other Intervention Names

Zegerid; Prilosec OTC Tablet

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CL2008-02

Identifier Type: -

Identifier Source: secondary_id

P07814

Identifier Type: OTHER

Identifier Source: secondary_id

18134

Identifier Type: -

Identifier Source: org_study_id