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

Bayer48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heartburn

Interventions

Omeprazole 20 mg + Sodium Bicarbonate 1100 mgDRUG

Capsules, orally

Omeprazole 20 mgDRUG

Tablets, orally

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Time-to-onset of Heartburn Relief

Time-to-onset of heartburn relief was defined as earliest time following start of treatment that participant experienced a reduction of at least one grade from baseline in the severity of heartburn. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows: Absent (0): Heartburn is not present. Mild (1): Heartburn did not last long or was easily tolerated. Moderate (2): Heartburn caused discomfort and interrupted usual activities. Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating.

Time frame: Start of treatment until onset of heartburn relief, up to 24 hours

Secondary Outcomes

Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time

Onset of heartburn relief was defined as a reduction of at least one grade from baseline in the severity of heartburn following start of treatment. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows: Absent (0): Heartburn is not present. Mild (1): Heartburn did not last long or was easily tolerated. Moderate (2): Heartburn caused discomfort and interrupted usual activities. Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating.

Time frame: Start of treatment until onset of heartburn relief, up to 72 hours

Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire

Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 1 asked participants to compare the 2 treatments for Heartburn Control.

Time frame: At end of study (approx. Study Day 40)

Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire

Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 2 asked participants to compare the 2 treatments for Heartburn Relief.

Data from ClinicalTrials.gov

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