GERD Clinical Trial
— EEOfficial title:
How Does Proton Pump Inhibitor Therapy Impact Quality of Life in Patients Newly Diagnosed With Erosive Reflux Esophagitis?
Verified date | August 2010 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | December 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 or older - Have either mild-to-moderate erosive reflux esophagitis - Meet criteria for GERD symptoms. Exclusion Criteria: - 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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
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