Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis - Full Text View

Purpose

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.

Condition

Errosive Esophagitis
Reflux Esophagitis
GERD

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	How Does Proton Pump Inhibitor Therapy Impact Quality of Life in Patients Newly Diagnosed With Erosive Reflux Esophagitis?

Further study details as provided by Mayo Clinic:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients age 18 and older, diagnosed with reflux esophagitis, being seen at Mayo Clinic Rocheser.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586963

Locations


United States, Minnesota
	Mayo Clinic	Enrolling by invitation
	Rochester, Minnesota, United States, 55955

Sponsors and Collaborators

Mayo Clinic

Investigators


Principal Investigator:	Yvonne Romero, MD.	Mayo Clinic

More Information

Responsible Party:	Mayo Clinic ( Yvonne Romero )
Study ID Numbers:	07-006142, IRUSESOM0488
First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00586963
Health Authority:	United States: Food and Drug Administration