Back to resultsComparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036)
Primary Purpose
Heartburn
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Omeprazole 20 mg
Sponsored by
About this trial
This is an interventional treatment trial for Heartburn focused on measuring Frequent Heartburn, Omeprazole, Omeprazole, sodium bicarbonate drug combination, Gastrointestinal Agents, Therapeutic Uses, Pharmacologic Actions, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Proton Pump Inhibitors
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Omeprazole 20 mg
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire
Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.
Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01587885
Brief Title
Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036)
Official Title
Protocol PT 11-29: Randomized, Open-label, Cross-over Pilot Study to Evaluate and Compare Two Omeprazole Containing Products for Relief of Frequent Heartburn
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn
Keywords
Frequent Heartburn, Omeprazole, Omeprazole, sodium bicarbonate drug combination, Gastrointestinal Agents, Therapeutic Uses, Pharmacologic Actions, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Proton Pump Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Arm Type
Experimental
Arm 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.
Arm Title
Omeprazole 20 mg
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Other Intervention Name(s)
Zegerid™
Intervention Description
Capsules, orally
Intervention Type
Drug
Intervention Name(s)
Omeprazole 20 mg
Other Intervention Name(s)
Prilosec OTC™
Intervention Description
Tablets, orally
Primary Outcome Measure Information:
Title
Time-to-onset of Heartburn Relief
Description
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 Outcome Measure Information:
Title
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time
Description
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
Title
Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire
Description
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)
Title
Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire
Description
Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 2 asked participants to compare the 2 treatments for Heartburn Relief.
Time Frame
At end of study (approx. Study Day 40)
Title
Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire
Description
Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.
Time Frame
At end of study (approx. Study Day 40)
Title
Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire
Description
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.
Time Frame
End of treatment period 1 and end of treatment period 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036)
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