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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01587885
• Collaborator: (none)
• Enrollment: 48
• Arms: 2
• Duration (Months): 4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heartburn	Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg; Drug: Omeprazole 20 mg	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2012
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

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™

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01587885
• Other Study ID Numbers: 18131; PT 11-29; 0764A-036
• First Posted: Apr 30, 2012
• Last Update Posted: Mar 11, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Bayer: Frequent Heartburn; Omeprazole; Omeprazole, sodium bicarbonate drug combination; Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Proton Pump Inhibitors
• Additional relevant MeSH terms: Heartburn; Omeprazole

Study Results

Participant Flow

Arm/Group Title	Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg	Omeprazole 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg
Arm/Group 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.
Period Title: Treatment Period 1
STARTED	26	22
COMPLETED	26	19
NOT COMPLETED	0	3
Period Title: Treatment Period 1
STARTED	26	19
COMPLETED	26	19
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All participants who were randomized and received study drug.
Overall Participants	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.3 (12.57)
Sex: Female, Male (Count of Participants)
Female	31 64.6%
Male	17 35.4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg	Omeprazole 20 mg
Arm/Group Description	Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.	Participants will receive omeprazole 20 mg once a day for 4 days.
Measure Participants	44	44
Median (Inter-Quartile Range) [Minutes]	30.0	60.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg, Omeprazole 20 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0480
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.548
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg	Omeprazole 20 mg
Arm/Group Description	Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.	Participants will receive omeprazole 20 mg once a day for 4 days.
Measure Participants	44	44
≤15 minutes	20.5 42.7%	13.6 NaN
≤30 minutes	52.3 109%	27.3 NaN
≤60 minutes	75.0 156.3%	61.4 NaN
≤90 minutes	90.9 189.4%	75.0 NaN
≤120 minutes	95.5 199%	88.6 NaN
≤180 minutes	100.0 208.3%	90.9 NaN
≤1440 minutes (24 hours)	100.0 208.3%	93.2 NaN
≤2880 minutes (48 hours)	100.0 208.3%	95.5 NaN
≤4320 minutes (72 hours)	100.0 208.3%	100.0 NaN

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Treated Participants
Arm/Group Description
Measure Participants	48
Preferred omeprazole+sodium bicarbonate	14 29.2%
Preferred omeprazole	17 35.4%
Preferred both equally	9 18.8%
Missing data	8 16.7%

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Treated Participants
Arm/Group Description
Measure Participants	48
Preferred omeprazole+sodium bicarbonate	16 33.3%
Preferred omeprazole	16 33.3%
Preferred both equally	7 14.6%
Preferred neither	1 2.1%
Missing data	8 16.7%

5. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	All Treated Participants
Arm/Group Description
Measure Participants	48
Preferred omeprazole+sodium bicarbonate	17 35.4%
Preferred omeprazole	17 35.4%
Preferred both equally	6 12.5%
Missing data	8 16.7%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg	Omeprazole 20 mg
Arm/Group Description	Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.	Participants will receive omeprazole 20 mg once a day for 4 days.
Measure Participants	40	40
heartburn symptoms affected daily activities	30.0	30.0
heartburn symtoms caused trouble falling asleep	27.5	25.0
heartburn symptoms awoke participant	22.5	32.5
slept on incline due to heartburn symptoms	35.0	47.5
medicine helped with full night's rest	90.0	95.0

Adverse Events

Adverse Event Reporting Description	Three participants discontinued the study prior to receiving Omeprazole 20 mg + Sodium Bicarbonate 1100 mg. Therefore, only 45 participants received Omeprazole 20 mg + Sodium Bicarbonate 1100 mg.
Arm/Group Title	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg		Omeprazole 20 mg
Arm/Group 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.
All Cause Mortality
	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg		Omeprazole 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg		Omeprazole 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg		Omeprazole 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.