HeartburnPhase 4NCT00206024
Acid-Associated Heartburn Symptoms and Dose of Esomeprazole
A Phase 4 study testing Esomeprazole magnesium (Nexium) in people with Heartburn, run by AstraZeneca at 27 sites in 2 countries.
Trial summary
This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heartburn
- What is being tested?
- Esomeprazole magnesium (Nexium)
- How many people
- 330 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Nov 2004to Jul 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent
- A history of heartburn for at least 6 months
- A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy
- A positive esophageal acid perfusion test
- At least 3 days of 'moderate' severity heartburn over the previous 7 days
- No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization
Who cannot join
- A history of gastric or esophageal surgery
- H. pylori positive
- A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization
- Currently taking higher than the standard approved proton pump inhibitor doses
- Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States26 sites
Research Site
Anaheim, California
Research Site
Annapolis, Maryland
Research Site
Asheville, North Carolina
Research Site
Atlanta, Georgia
Research Site
Attleboro, Massachusetts
Research Site
Baltimore, Maryland
Research Site
Chicago, Illinois
Research Site
Christiansburg, Virginia
Research Site
DeLand, Florida
Research Site
Elkin, North Carolina
Research Site
Guthrie, Oklahoma
Research Site
Hackensack, New Jersey
Research Site
Hollywood, Maryland
Research Site
Knoxville, Tennessee
Research Site
Miami, Florida
Research Site
New Orleans, Louisiana
Research Site
New Smyrna Beach, Florida
Research Site
Orange, California
Research Site
Philadelphia, Pennsylvania
Research Site
Rochester, New York
Research Site
San Diego, California
Research Site
Tampa, Florida
Research Site
Tucson, Arizona
Research Site
Vineland, New Jersey
Research Site
Washington D.C., District of Columbia
Research Site
Zephyrhills, Florida
About this study
Official title: A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium
This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.
- Conditions
- Heartburn
- Being tested
- Esomeprazole magnesium (Nexium)
- Medical subject headings
- Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole magnesium (Nexium)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".
Secondary outcomes (7)
Relief of heartburn during the 4th week of treatment
Cumulative daily sustained resolution rate through 4 weeks of treatment
Time to first day of the first 7-day period of sustained resolution of heartburn
Time to the first day of the first 7-day period of relief of heartburn
Percentage of subject-reported heartburn-free days through 4 weeks of treatment
Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartburnStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 330 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nexium Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206024
- Sponsor's protocol ID
- D9612L00064
- Status last verified
- Nov 2010
- First submitted
- 12 Sep 2005
- Last updated
- 19 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium
- ClinicalTrials.gov ID
- NCT00206024
- Acronym / sponsor ID
- D9612L00064
- Conditions
- Heartburn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Jul 2005 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent
- A history of heartburn for at least 6 months
- A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy
- A positive esophageal acid perfusion test
- At least 3 days of 'moderate' severity heartburn over the previous 7 days
Key exclusion criteria (5 listed)
- A history of gastric or esophageal surgery
- H. pylori positive
- A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization
- Currently taking higher than the standard approved proton pump inhibitor doses
- Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.
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 magnesium (Nexium) | Drug | – |
Primary outcome
Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".
7 secondary outcomes
Relief of heartburn during the 4th week of treatment
Cumulative daily sustained resolution rate through 4 weeks of treatment
Time to first day of the first 7-day period of sustained resolution of heartburn
Time to the first day of the first 7-day period of relief of heartburn
Percentage of subject-reported heartburn-free days through 4 weeks of treatment
Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
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A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
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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.
Nexium Medical Science Director, MD study director
AstraZeneca
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole magnesium (Nexium) in people with Heartburn, run by AstraZeneca at 27 sites in 2 countries.
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 6 inclusion and 5 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 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Puerto Rico. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2010.