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OpenTrials
Completed

NCT Number: NCT00586963

Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: EE

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 7, 2008
Registry last updated
Aug 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.