Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis

GERD Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586963
• Other study ID #: 07-006142
• Secondary ID: IRUSESOM0488
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: August 20, 2010
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erosive Esophagitis
• Esophagitis
• Esophagitis, Peptic
• GERD
• Reflux Esophagitis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,