Erosive EsophagitisEENCT00586963
Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis
An observational study of Erosive Esophagitis and Reflux Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to for two reasons: To learn about the effects (good and bad) esomeprazole (an FDA approved drug for reflux esophagitis) has on your esophagus when taken correctly. To learn about the quality of life changes (good and bad) you may experience with this medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erosive Esophagitis, Reflux Esophagitis, GERD
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients age 18 and older, diagnosed with reflux esophagitis, being seen at Mayo Clinic Rocheser.
Who may be able to join
- Age 18 or older
- Have either mild-to-moderate erosive reflux esophagitis
- Meet criteria for GERD symptoms.
Who cannot join
- Patients already on esomeprazole therapy, have previously failed to respond to esomeprazole, or are intolerant to PPI therapy.
- Patients expected to travel outside of the United States during the initial 8 weeks of PPI therapy.
- Pregnant women will be excluded as PPI's are not thought safe for the fetus (Pregnancy Category C). - Children younger than 18 years of age will be excluded.
- Other vulnerable populations, such as those with diminished mental acuity, will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Does Proton Pump Inhibitor Therapy Impact Quality of Life in Patients Newly Diagnosed With Erosive Reflux Esophagitis?
This study is being done to for two reasons:
- To learn about the effects (good and bad) esomeprazole (an FDA approved drug for reflux esophagitis) has on your esophagus when taken correctly.
- To learn about the quality of life changes (good and bad) you may experience with this medication.
Read the detailed description
The plan is to have 50 people take part in this study at Mayo Clinic Rochester. This research study is looking at people who have a new condition called erosive reflux esophagitis. Esophagitis is defined as mucosal damage produced by the abnormal reflux of gastric contents into the esophagus. Acid reflux, over time, can wear away or erode the lining of your esophagus. This condition is called erosive esophagitis. The treating physician may start you on prescription strength acid reducing group of medications called Proton Pump Inhibitors (PPI). PPI medications can provide 24-hour relief from your painful heartburn symptoms and it can help you heal the erosions in the esophagus that acid reflux may cause.
- Conditions
- Erosive Esophagitis, Reflux Esophagitis, GERD
- Keywords
- Erosive Esophagitis, Reflux Esophagitis, GERD
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Yvonne Romero, MD., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586963
- Sponsor's protocol ID
- 07-006142
- Other IDs
- IRUSESOM0488
- Acronym
- EE
- Status last verified
- Aug 2010
- First submitted
- 21 Dec 2007
- Last updated
- 23 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Proton Pump Inhibitor Therapy Impact Quality of Life in Patients Newly Diagnosed With Erosive Reflux Esophagitis?
- ClinicalTrials.gov ID
- NCT00586963
- Acronym / sponsor ID
- EE / 07-006142
- Conditions
- Erosive Esophagitis, Reflux Esophagitis, GERD
- Keywords
- Erosive Esophagitis, Reflux Esophagitis, GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jan 2008 (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 study is being done to for two reasons:
- To learn about the effects (good and bad) esomeprazole (an FDA approved drug for reflux esophagitis) has on your esophagus when taken correctly.
- To learn about the quality of life changes (good and bad) you may experience with this medication.
Detailed description
The plan is to have 50 people take part in this study at Mayo Clinic Rochester. This research study is looking at people who have a new condition called erosive reflux esophagitis. Esophagitis is defined as mucosal damage produced by the abnormal reflux of gastric contents into the esophagus. Acid reflux, over time, can wear away or erode the lining of your esophagus. This condition is called erosive esophagitis. The treating physician may start you on prescription strength acid reducing group of medications called Proton Pump Inhibitors (PPI). PPI medications can provide 24-hour relief from your painful heartburn symptoms and it can help you heal the erosions in the esophagus that acid reflux may cause.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients age 18 and older, diagnosed with reflux esophagitis, being seen at Mayo Clinic Rocheser.
Key inclusion criteria (3 listed)
- Age 18 or older
- Have either mild-to-moderate erosive reflux esophagitis
- Meet criteria for GERD symptoms.
Key exclusion criteria (4 listed)
- Patients already on esomeprazole therapy, have previously failed to respond to esomeprazole, or are intolerant to PPI therapy.
- Patients expected to travel outside of the United States during the initial 8 weeks of PPI therapy.
- Pregnant women will be excluded as PPI's are not thought safe for the fetus (Pregnancy Category C). - Children younger than 18 years of age will be excluded.
- Other vulnerable populations, such as those with diminished mental acuity, will be excluded.
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
Not reported in the source record.
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 23 Aug 2010.
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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.
Yvonne Romero, MD. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erosive Esophagitis and Reflux Esophagitis, run by Mayo Clinic at 1 site 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 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 23 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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.
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 23 Aug 2010.