Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis (EE)

August 20, 2010 updated by: Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55955
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Yvonne Romero, MD., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 23, 2010

Last Update Submitted That Met QC Criteria

August 20, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-006142
  • IRUSESOM0488

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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