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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586963
First received: December 21, 2007
Last updated: August 20, 2010
Last verified: August 2010
History of Changes
  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
Erosive Esophagitis
Reflux Esophagitis
GERD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Does Proton Pump Inhibitor Therapy Impact Quality of Life in Patients Newly Diagnosed With Erosive Reflux Esophagitis?

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Enrollment: 65
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (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
Rochester, Minnesota, United States, 55955
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Yvonne Romero, MD. Mayo Clinic
  More Information

No publications provided

Responsible Party: Yvonne Romero, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586963     History of Changes
Other Study ID Numbers: 07-006142, IRUSESOM0488
Study First Received: December 21, 2007
Last Updated: August 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Erosive Esophagitis
Reflux Esophagitis
GERD

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Peptic Ulcer
Esophageal Motility Disorders
Deglutition Disorders
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013