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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00586963
Collaborator
(none)
65
Enrollment
1
Location
11
Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    65 participants
    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?
    Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Oct 1, 2008
    Actual Study Completion Date :
    Dec 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Mayo Clinic Rochester Minnesota United States 55955

      Sponsors and Collaborators

      • Mayo Clinic

      Investigators

      • Principal Investigator: Yvonne Romero, MD., Mayo Clinic

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00586963
      Other Study ID Numbers:
      • 07-006142
      • IRUSESOM0488
      First Posted:
      Jan 7, 2008
      Last Update Posted:
      Aug 23, 2010
      Last Verified:
      Aug 1, 2010
      Keywords provided by , ,
      Erosive Esophagitis
      Reflux Esophagitis
      GERD
      Additional relevant MeSH terms:
      Esophagitis
      Esophagitis, Peptic

      Study Results

      No Results Posted as of Aug 23, 2010