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

Protocol PT 11-29: Randomized, Open-label, Cross-over Pilot Study to Evaluate and Compare Two Omeprazole Containing Products for Relief of Frequent Heartburn

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 Overview

• Status: Completed
• Conditions: Heartburn
• Intervention / Treatment: Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg; Drug: Omeprazole 20 mg

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg; Capsules, orally; Other Names: Zegerid™; Drug: Omeprazole 20 mg; Tablets, orally; Other Names: Prilosec OTC™
ACTIVE_COMPARATOR: 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.	Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg; Capsules, orally; Other Names: Zegerid™; Drug: Omeprazole 20 mg; Tablets, orally; 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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: April 4, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (ESTIMATE): April 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 11, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Enzyme Inhibitors; Pharmacologic Actions; Therapeutic Uses; Omeprazole; Proton Pump Inhibitors; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Frequent Heartburn; Omeprazole, sodium bicarbonate drug combination
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole
• Other Study ID Numbers: 18131; PT 11-29 (OTHER: Study Number); 0764A-036 (OTHER: Merck)