A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)

NCT ID: NCT00674115

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-06-30

Brief Summary

Open-label randomized crossover design studies. 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. The other 30 participants will receive a single administration of sodium bicarbonate.

Detailed Description

Enrolled participants were divided into 2 groups, with 30 participants in each group.

Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (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. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension 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 also underwent 24-hour intragastric pH recordings on the days on 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 and Zegerid Powder for Oral Suspension 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

Single Dose Zegerid for 1 or 7 days

Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension

Group Type: EXPERIMENTAL

Omeprazole/sodium bicarbonate

Intervention Type: DRUG

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

Single Dose Prilosec 1 or 7 days

Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet

Group Type: ACTIVE_COMPARATOR

omeprazole magnesium

Intervention Type: DRUG

Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.

Sodium Bicarbonate

Sodium Bicarbonate 1680 mg Oral Suspension

Group Type: ACTIVE_COMPARATOR

sodium bicarbonate

Intervention Type: DRUG

Sodium bicarbonate. Single dose.

Interventions

Omeprazole/sodium bicarbonate

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

Intervention Type: DRUG

omeprazole magnesium

Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.

Intervention Type: DRUG

sodium bicarbonate

Sodium bicarbonate. Single dose.

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

CL2007-17

Identifier Type: -

Identifier Source: secondary_id

P07813

Identifier Type: OTHER

Identifier Source: secondary_id

18133

Identifier Type: -

Identifier Source: org_study_id