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

Bayer

Status and phase: Completed; Phase 4

Conditions: Heartburn

Treatments: Drug: Omeprazole 20 mg; Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01587885

0764A-036 (Other Identifier)

PT 11-29 (Other Identifier)

18131

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Experimental group

Description:

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.

Treatment:

Drug: Omeprazole 20 mg

Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Omeprazole 20 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Omeprazole 20 mg

Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg