CClinicalTrials.gg
CompletedNCT00586963EEUpdated Aug 23, 2010

Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis

An observational study in Erosive Esophagitis, Reflux Esophagitis and GERD, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-23.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
18 Years and older
Sex
All
01

Study summary

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.
Read the 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.

02

Conditions studied

  • Erosive Esophagitis
  • Reflux Esophagitis
  • GERD

Keywords

  • Erosive Esophagitis
  • Reflux Esophagitis
  • GERD
03

In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's enrollment of 65 is below the median of 100 across 91 observational studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

  • Age 18 or older
  • Have either mild-to-moderate erosive reflux esophagitis
  • Meet criteria for GERD symptoms.

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (actual)
06

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55955, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00586963
Lead sponsor
Mayo Clinic
First posted
Jan 7, 2008
Start date
Jan 2008
Primary completion
Oct 2008
Completion
Dec 2008
Last update
Aug 23, 2010

Study contacts

Yvonne Romero, MD.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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