Reflux EsophagitisOMAREENCT00859287
Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis
An observational study of Reflux Esophagitis, run by AstraZeneca.
Trial summary
This open label, non-interventional study is to compare the efficacy of Omepral® tablet and any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various type of acid reflux related symptoms in patients with reflux esophagitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Reflux Esophagitis
- How many people
- 10,703 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Jul 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients endoscopically diagnosed as erosive esophagitis accompanied with either two days or more heartburn or acid taste in the mouth of any severity
Who may be able to join
- Patients newly diagnosed as erosive esophagitis or history of erosive esophagitis confirmed by endoscopy.
- Patients who answered questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
- During the past 1 week , patients who have either two days or more with heartburn or acid taste in the mouth of any severity
Who cannot join
- Patients receiving treatment with proton pump inhibitors, which make stomach acid decreased during the last 4 weeks prior to enrolment.
- Patients who cannot answer questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
- Patients included previously in this study.
About this study
Official title: Omepral® Tablets Mega-study to Investigate the Efficacy on Various Type of Acid Reflux Related Symptoms and QOL, and Epidemiology in Patients With Erosive Esophagitis in Daily Medical Practice
This open label, non-interventional study is to compare the efficacy of Omepral® tablet and any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various type of acid reflux related symptoms in patients with reflux esophagitis.
- Conditions
- Reflux Esophagitis
- Keywords
- Reflux esophagitis, Omepral®, QOLRAD
- Medical subject headings
- Esophagitis, Peptic
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients symptom evaluated by investigator
Measured: at entry, 4 weeks and 8 weeks
Patients reported symptom
Measured: at entry, 4 weeks and 8 weeks
Secondary outcomes (2)
Patients reported outcome score
Measured: at entry, 4 weeks and 8 weeks
Adverse event
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startJun 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reflux EsophagitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,703 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Japan Medical Director MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859287
- Sponsor's protocol ID
- NIS-GJP-DUM-2007/1
- Acronym
- OMAREE
- Status last verified
- Jul 2009
- First submitted
- 10 Mar 2009
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Yoshida S, Nii M, Date M. Effects of omeprazole on symptoms and quality of life in Japanese patients with reflux esophagitis: final results of OMAREE, a large-scale clinical experience investigation. BMC Gastroenterol. 2011 Feb 28;11:15. doi: 10.1186/1471-230X-11-15.
PubMed 21356058
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omepral® Tablets Mega-study to Investigate the Efficacy on Various Type of Acid Reflux Related Symptoms and QOL, and Epidemiology in Patients With Erosive Esophagitis in Daily Medical Practice
- ClinicalTrials.gov ID
- NCT00859287
- Acronym / sponsor ID
- OMAREE / NIS-GJP-DUM-2007/1
- Conditions
- Reflux Esophagitis
- Keywords
- Reflux esophagitis, Omepral®, QOLRAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,703 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Mar 2009 (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 open label, non-interventional study is to compare the efficacy of Omepral® tablet and any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various type of acid reflux related symptoms in patients with reflux esophagitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients endoscopically diagnosed as erosive esophagitis accompanied with either two days or more heartburn or acid taste in the mouth of any severity
Key inclusion criteria (3 listed)
- Patients newly diagnosed as erosive esophagitis or history of erosive esophagitis confirmed by endoscopy.
- Patients who answered questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
- During the past 1 week , patients who have either two days or more with heartburn or acid taste in the mouth of any severity
Key exclusion criteria (3 listed)
- Patients receiving treatment with proton pump inhibitors, which make stomach acid decreased during the last 4 weeks prior to enrolment.
- Patients who cannot answer questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
- Patients included previously in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients symptom evaluated by investigator
Time frame: at entry, 4 weeks and 8 weeks
Patients reported symptom
Time frame: at entry, 4 weeks and 8 weeks
2 secondary outcomes
Patients reported outcome score
Time frame: at entry, 4 weeks and 8 weeks
Adverse event
Time frame: 8 weeks
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 15 Jul 2009.
- Derived from this study: PubMed 21356058Yoshida S, Nii M, Date M. Effects of omeprazole on symptoms and quality of life in Japanese patients with reflux esophagitis: final results of OMAREE, a large-scale clinical experience investigation. BMC Gastroenterol. 2011 Feb 28;11:15. doi: 10.1186/1471-230X-11-15.
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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.
AstraZeneca Japan Medical Director MD study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
An observational study of Reflux Esophagitis, run by AstraZeneca.
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 15 Jul 2009. 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.
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?
Patients symptom evaluated by investigator (time frame: at entry, 4 weeks and 8 weeks). 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 NCT00859287, 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 15 Jul 2009.