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

Mayo Clinic logo

Mayo Clinic

Status

Completed

Conditions

Reflux Esophagitis
Erosive Esophagitis
GERD

Study type

Observational

Funder types

Other

Identifiers

NCT00586963
IRUSESOM0488
07-006142

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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