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

Study Overview
=================
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.

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

Conditions
-----------------
Heartburn

Intervention / Treatment
-----------------
* Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
* Drug: Omeprazole 20 mg


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg<br>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. | Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg<br>* Capsules, orally<br>* Other names: Zegerid™;Drug: Omeprazole 20 mg<br>* Tablets, orally<br>* Other names: Prilosec OTC™;|
| Active Comparator: Omeprazole 20 mg<br>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. | Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg<br>* Capsules, orally<br>* Other names: Zegerid™;Drug: Omeprazole 20 mg<br>* Tablets, orally<br>* Other names: Prilosec OTC™;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Start of treatment until onset of heartburn relief, up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | At end of study (approx. Study Day 40) | 
| 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. | At end of study (approx. Study Day 40) | 
| 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. | End of treatment period 1 and end of treatment period 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frequent Heartburn, Omeprazole, Omeprazole, sodium bicarbonate drug combination, Gastrointestinal Agents, Therapeutic Uses, Pharmacologic Actions, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Proton Pump Inhibitors