HeartburnPhase 4NCT02708355
Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
A Phase 4 study testing Esomeprazole 20 mg in people with Heartburn, run by Pfizer at 2 sites in United States.
Trial summary
The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Heartburn
- What is being tested?
- Esomeprazole 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Apr 2016
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at least 3 months, while treating with gastric acid modulating therapy (antacids, H2 receptor antagonists (H2RAs) and/or PPIs).
- Heartburn symptoms that average 3 times per week or greater including at least 2 episodes of nighttime heartburn symptoms per week over the past 30 days.
- When heartburn medications were used, subject had heartburn symptoms that were responsive to antacids, non prescription H2RAs, or short term non prescription or prescription PPIs at approved doses but complete resolution of heartburn was not achieved.
Who cannot join
- A history (past or present) of erosive esophagitis verified by endoscopy.
- The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or antacids for any indication through the study (eg, long term prescription therapy).
- Subjects requiring continuous intervention by a physician for the treatment of GERD (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73102
St. Anthony Hospital - Conference Rooms
Oklahoma City, Oklahoma, 73102
About this study
Official title: A Pilot Phase IV, Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel Study To Investigate The Correlation Between Ph Control And Heartburn Symptoms After 14 Days Of Proton Pump Inhibitor Treatment In Subjects With Frequent Heartburn
The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.
- Conditions
- Heartburn
- Being tested
- Esomeprazole 20 mg, Placebo
- Medical subject headings
- Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 20 mgDrug
Also called Nexium
Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)
PlaceboDrug
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole 20 mg once daily | Experimental | Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening Receives: Drug: Esomeprazole 20 mg; Drug: Placebo |
| Esomeprazole 20 mg twice daily | Experimental | Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening Receives: Drug: Esomeprazole 20 mg |
| Placebo | Placebo comparator | Placebo administered orally in the morning and placebo administered orally in the evening Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn
Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported.
Measured: Day 8 up to Day 14
Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4
Percentage of time was calculated over the 24 hour period during which intra gastric pH >4 was observed. Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome, change from baseline at Day 14 in percentage of time over the 24 hour period during which intra gastric pH >4 was observed, was reported.
Measured: Baseline, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionApr 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeartburnStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708355
- Sponsor's protocol ID
- B5141005
- Other IDs
- ACID CONTROL EXPLORATORY STUDY
- Status last verified
- Mar 2017
- First submitted
- 21 Jan 2016
- Last updated
- 19 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Miner PB, Johnson DA, Katz PO, Li J, Gatoulis SC, Pollack C. Pilot, Randomized, Blinded, Placebo-Controlled Trial Investigating the Correlation Between Acid Control and Heartburn Relief with 14 Days of Esomeprazole Treatment. Adv Ther. 2018 Nov;35(11):2024-2040. doi: 10.1007/s12325-018-0792-z. Epub 2018 Sep 25.
PubMed 30255418
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase IV, Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel Study To Investigate The Correlation Between Ph Control And Heartburn Symptoms After 14 Days Of Proton Pump Inhibitor Treatment In Subjects With Frequent Heartburn
- ClinicalTrials.gov ID
- NCT02708355
- Acronym / sponsor ID
- B5141005
- Conditions
- Heartburn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Posted 19 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole 20 mg once daily | Experimental | Drug: Esomeprazole 20 mg, Drug: PlaceboEsomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening |
| Esomeprazole 20 mg twice daily | Experimental | Drug: Esomeprazole 20 mgEsomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered orally in the morning and placebo administered orally in the evening |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at least 3 months, while treating with gastric acid modulating therapy (antacids, H2 receptor antagonists (H2RAs) and/or PPIs).
- Heartburn symptoms that average 3 times per week or greater including at least 2 episodes of nighttime heartburn symptoms per week over the past 30 days.
- When heartburn medications were used, subject had heartburn symptoms that were responsive to antacids, non prescription H2RAs, or short term non prescription or prescription PPIs at approved doses but complete resolution of heartburn was not achieved.
Key exclusion criteria (3 listed)
- A history (past or present) of erosive esophagitis verified by endoscopy.
- The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or antacids for any indication through the study (eg, long term prescription therapy).
- Subjects requiring continuous intervention by a physician for the treatment of GERD (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).
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 |
|---|---|---|
| Esomeprazole 20 mgAlso: NexiumEsomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate) | Drug | Esomeprazole 20 mg once daily, Esomeprazole 20 mg twice daily |
| PlaceboPlacebo capsules | Drug | Esomeprazole 20 mg once daily, Placebo |
Primary outcome
Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn
Time frame: Day 8 up to Day 14
Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported.
Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4
Time frame: Baseline, Day 14
Percentage of time was calculated over the 24 hour period during which intra gastric pH >4 was observed. Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome, change from baseline at Day 14 in percentage of time over the 24 hour period during which intra gastric pH >4 was observed, was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30255418Miner PB, Johnson DA, Katz PO, Li J, Gatoulis SC, Pollack C. Pilot, Randomized, Blinded, Placebo-Controlled Trial Investigating the Correlation Between Acid Control and Heartburn Relief with 14 Days of Esomeprazole Treatment. Adv Ther. 2018 Nov;35(11):2024-2040. doi: 10.1007/s12325-018-0792-z. Epub 2018 Sep 25.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole 20 mg in people with Heartburn, run by Pfizer at 2 sites in United States.
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 3 inclusion and 3 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 19 Apr 2017). 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?
Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn (time frame: Day 8 up to Day 14). The study lists 2 primary outcomes in all. 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 NCT02708355, which also lists 1 linked publication.
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 19 Apr 2017.