HeartburnPhase 4NCT01587885

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

A Phase 4 study testing Omeprazole 20 mg + Sodium Bicarbonate 1100 mg and Omeprazole 20 mg in people with Heartburn, run by Bayer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Heartburn
What is being tested?: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg and Omeprazole 20 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: Jan 2012to May 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

About this study

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

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.

Conditions: Heartburn
Being tested: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg, Omeprazole 20 mg
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
Medical subject headings: Heartburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omeprazole 20 mg + Sodium Bicarbonate 1100 mgDrug
Also called Zegerid™
Capsules, orally
Omeprazole 20 mgDrug
Also called Prilosec OTC™
Tablets, orally

Study groups in NCT01587885
Study group	Role	What they receive
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg	Experimental	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. Receives: Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg; Drug: Omeprazole 20 mg
Omeprazole 20 mg	Active comparator	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. Receives: Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg; Drug: Omeprazole 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of treatment period 1 and end of treatment period 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012May 2012

First posted30 Apr 2012 (estimated)
Study startJan 2012
Primary completionApr 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HeartburnStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01587885
Sponsor's protocol ID: 18131
Other IDs: PT 11-29, 0764A-036
Status last verified: Feb 2015
First submitted: 4 Apr 2012
Last updated: 11 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia

All Heartburn trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01587885
Acronym / sponsor ID: 18131
Conditions: Heartburn
Keywords: Frequent Heartburn, Omeprazole, Omeprazole, sodium bicarbonate drug combination, Gastrointestinal Agents, Therapeutic Uses, Pharmacologic Actions, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Apr 2012 (actual)
Study completion: May 2012 (actual)
First posted: 30 Apr 2012 (estimated)
Results: Posted 22 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg	Experimental	Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg, Drug: Omeprazole 20 mgParticipants 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 20 mg	Active comparator	Drug: Omeprazole 20 mg + Sodium Bicarbonate 1100 mg, Drug: Omeprazole 20 mgParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omeprazole 20 mg + Sodium Bicarbonate 1100 mgAlso: Zegerid™Capsules, orally	Drug	Omeprazole 20 mg, Omeprazole 20 mg + Sodium Bicarbonate 1100 mg
Omeprazole 20 mgAlso: Prilosec OTC™Tablets, orally	Drug	Omeprazole 20 mg, Omeprazole 20 mg + Sodium Bicarbonate 1100 mg

Primary outcome

Time-to-onset of Heartburn Relief
Time frame: 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.

5 secondary outcomes

Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time
Time frame: Start of treatment until onset of heartburn relief, up to 72 hours
Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire
Time frame: At end of study (approx. Study Day 40)
Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire
Time frame: At end of study (approx. Study Day 40)
Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire
Time frame: At end of study (approx. Study Day 40)
Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire
Time frame: End of treatment period 1 and end of treatment period 2

Results and safety

Results posted to the registry on 22 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg	26	26
Omeprazole 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg	22	19

Primary outcome: Time-to-onset of Heartburn Relief

Time frame: Start of treatment until onset of heartburn relief, up to 24 hours. Median (Inter-Quartile Range). Unit: Minutes

Measure	Omeprazole 20 mg + Sodium Bicarbonate 1100 mg n = 44	Omeprazole 20 mg n = 44
Value	30.0 (30.0 to 75.0)	60.0 (30.0 to 105.0)

Omeprazole 20 mg + Sodium Bicarbonate 1100 mg vs Omeprazole 20 mg: Hazard Ratio (HR): 1.548, p <0.0480, Regression, Cox

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omeprazole 20 mg + Sodium Bicarbonate 1100 mg	0 of 45 (0%)	0 of 45 (0%)	Not reported
Omeprazole 20 mg	0 of 48 (0%)	0 of 48 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heartburn

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Enrolling by invitationObservational study
The Johns Hopkins Heartburn Center Registry
Gastroesophageal Reflux Disease, Barrett Esophagus
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Omeprazole 20 mg + Sodium Bicarbonate 1100 mg and Omeprazole 20 mg in people with Heartburn, run by Bayer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-onset of Heartburn Relief (time frame: Start of treatment until onset of heartburn relief, up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01587885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.