Trial Outcomes & Findings for Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036) (NCT NCT01587885)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

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

Results posted on

2015-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg 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 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg 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.
Treatment Period 1 STARTED	26	22
Treatment Period 1 COMPLETED	26	19
Treatment Period 1 NOT COMPLETED	0	3
Treatment Period 2 STARTED	26	19
Treatment Period 2 COMPLETED	26	19
Treatment Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg 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 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg 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.
Treatment Period 1 Failure to Return	0	1
Treatment Period 1 Protocol Violation	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=48 Participants All participants who were randomized and received study drug.
Age, Continuous	48.3 years STANDARD_DEVIATION 12.57 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

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

Population: Participants in the modified Intent-to-Treat (mITT) population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed. One participant completed the study but the participant's data was corrupted and therefore not included.

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.

Outcome measures

Outcome measures
Measure	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg n=44 Participants Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.	Omeprazole 20 mg n=44 Participants Participants will receive omeprazole 20 mg once a day for 4 days.
Time-to-onset of Heartburn Relief	30.0 Minutes Interval 30.0 to 75.0	60.0 Minutes Interval 30.0 to 105.0

SECONDARY outcome

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

Population: Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed. One participant completed the study but the participant's data was corrupted and therefore not included.

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.

Outcome measures

Outcome measures
Measure	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg n=44 Participants Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.	Omeprazole 20 mg n=44 Participants Participants will receive omeprazole 20 mg once a day for 4 days.
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time ≤15 minutes	20.5 percentage of participants	13.6 percentage of participants
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time ≤30 minutes	52.3 percentage of participants	27.3 percentage of participants
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time ≤60 minutes	75.0 percentage of participants	61.4 percentage of participants
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time ≤90 minutes	90.9 percentage of participants	75.0 percentage of participants
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time ≤120 minutes	95.5 percentage of participants	88.6 percentage of participants
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time ≤180 minutes	100.0 percentage of participants	90.9 percentage of participants
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time ≤1440 minutes (24 hours)	100.0 percentage of participants	93.2 percentage of participants
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time ≤2880 minutes (48 hours)	100.0 percentage of participants	95.5 percentage of participants
Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time ≤4320 minutes (72 hours)	100.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

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

Population: Participants in the Intent-to-Treat (ITT) population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.

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

Outcome measures

Outcome measures
Measure	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg n=48 Participants Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.	Omeprazole 20 mg Participants will receive omeprazole 20 mg once a day for 4 days.
Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire Preferred omeprazole+sodium bicarbonate	14 participants	—
Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire Preferred omeprazole	17 participants	—
Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire Preferred both equally	9 participants	—
Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire Missing data	8 participants	—

SECONDARY outcome

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

Population: Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.

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

Outcome measures

Outcome measures
Measure	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg n=48 Participants Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.	Omeprazole 20 mg Participants will receive omeprazole 20 mg once a day for 4 days.
Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire Preferred omeprazole+sodium bicarbonate	16 participants	—
Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire Preferred omeprazole	16 participants	—
Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire Preferred both equally	7 participants	—
Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire Preferred neither	1 participants	—
Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire Missing data	8 participants	—

SECONDARY outcome

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

Population: Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.

Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.

Outcome measures

Outcome measures
Measure	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg n=48 Participants Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.	Omeprazole 20 mg Participants will receive omeprazole 20 mg once a day for 4 days.
Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire Preferred omeprazole+sodium bicarbonate	17 participants	—
Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire Preferred omeprazole	17 participants	—
Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire Preferred both equally	6 participants	—
Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire Missing data	8 participants	—

SECONDARY outcome

Timeframe: End of treatment period 1 and end of treatment period 2

Population: Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.

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.

Outcome measures

Outcome measures
Measure	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg n=40 Participants Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.	Omeprazole 20 mg n=40 Participants Participants will receive omeprazole 20 mg once a day for 4 days.
Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire heartburn symptoms affected daily activities	30.0 percentage of partcipants	30.0 percentage of partcipants
Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire heartburn symtoms caused trouble falling asleep	27.5 percentage of partcipants	25.0 percentage of partcipants
Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire heartburn symptoms awoke participant	22.5 percentage of partcipants	32.5 percentage of partcipants
Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire slept on incline due to heartburn symptoms	35.0 percentage of partcipants	47.5 percentage of partcipants
Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire medicine helped with full night's rest	90.0 percentage of partcipants	95.0 percentage of partcipants

Adverse Events

Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omeprazole 20 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MERCK retains the title to and exclusive right to publish all documentation, research data, records, raw data, other work product, data, and/or results generated with respect to the Services and/or the Study ("Work Product"). Such Work Product will be retained in the CRO archive in compliance with regulatory requirements.
Publication restrictions are in place

Restriction type: OTHER