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

Phase 4

Completed

• Conditions: Heartburn
• Interventions: Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg; Drug: Omeprazole 20 mg

• Registration Number: NCT01587885
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-04
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Study Completion: 2012-05
• Results First Submitted: 2013-04-04
• Results First Submitted QC: 2013-04-04
• Results First Posted: 2013-05-22
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg	Omeprazole 20 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.
Omeprazole 20 mg	Omeprazole 20 mg + Sodium Bicarbonate 1100 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.
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg	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.
Omeprazole 20 mg	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.

Primary Outcome Measures

Name	Time	Method
Time-to-onset of Heartburn Relief	Start of treatment until onset of heartburn relief, up to 24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire	At end of study (approx. Study Day 40)	Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 2 asked participants to compare the 2 treatments for Heartburn Relief.
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time	Start of treatment until onset of heartburn relief, up to 72 hours	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.
Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire	End of treatment period 1 and end of treatment period 2	End of Treatment Quality of Life was based on a questionnaire regarding quality-of-life issues associated with heartburn, completed by participants at the end of treatment period 1 and the end of treatment period 2.
Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire	At end of study (approx. Study Day 40)	Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 1 asked participants to compare the 2 treatments for Heartburn Control.
Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire	At end of study (approx. Study Day 40)	Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.