Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

Brief Summary

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This study will evaluate a single ingredient product (omeprazole 20 mg) with a combination product capsule (omeprazole 20 mg + sodium bicarbonate 1100 mg) in participants with frequent heartburn.

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Detailed Description

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Conditions

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Heartburn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.

Group Type EXPERIMENTAL

Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Intervention Type DRUG

Capsules, orally

Omeprazole 20 mg

Intervention Type DRUG

Tablets, orally

Omeprazole 20 mg

Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.

Group Type ACTIVE_COMPARATOR

Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Intervention Type DRUG

Capsules, orally

Omeprazole 20 mg

Intervention Type DRUG

Tablets, orally

Interventions

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Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Capsules, orally

Intervention Type DRUG

Omeprazole 20 mg

Tablets, orally

Intervention Type DRUG

Other Intervention Names

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Zegerid™ Prilosec OTC™

Eligibility Criteria

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Inclusion Criteria

* Females of reproductive potential must demonstrate a negative urine pregnancy test and agree to use an acceptable method of birth control
* Suffer from frequent heartburn
* Refrain from taking non-study medicine or treatment for heartburn for the duration of the study
* Be free of any clinically significant disease that requires a physician's care
* Read and understand English

Exclusion Criteria

* Any significant medical condition which is a contraindication to the use of omeprazole or sodium bicarbonate
* Known hypersensitivity to the study drugs or any components
* Experiencing any of the following: trouble or pain with swallowing food, vomiting with blood, bloody or black stools
* Participation in another investigational study within 4 weeks prior to the screening visit.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes