Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD

Last updated: August 18, 2010
Sponsor: Southern Arizona VA Health Care System
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Heartburn

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT01089959
ISS Astra Zeneca 7 day Nexium
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only nighttime symptoms but also significantly reduces conscious awakenings associated with gastroesophageal reflux and consequently improves sleep quality.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Nocturnal symptoms at least twice a week.

  • Ages 18-80

  • Erosive esophagitis and/or abnormal pH test -

  • Able to read, understand, and complete study questionnaires

Exclusion

Exclusion Criteria:

  • Subjects with Barrett's esophagus or peptic stricture on endoscopy

  • Subjects with normal endoscopy and pH test

  • Subjects with previous upper gastrointestinal surgery

Study Design

Total Participants: 20
Study Start date:
March 01, 2010
Estimated Completion Date:
March 31, 2012

Study Description

Twenty GERD patients with nighttime heartburn and/or regurgitation at least 3 times a week will be invited to participate in the study. All patients will undergo upper endoscopy to determine presence or absence of esophageal inflammation(using Los Angeles criteria). All patients will be evaluated by the Demographic,Berlin,Epworth Sleepiness Scale Questionnaires, and GERD Symptom Checklist. Thereafter,patients will undergo pH testing w/ an actigraph.The morning of pH probe removal,a Sleep Quality Questionaire will be administered.

Subjects will then receive esomeprazole 40 mg. once daily(30 minutes before breakfast) for 1 week. On day 7,subjects will again undergo pH testing w/ actigraphy, and the results will be analyzed again w/ new integrative software. On the morning of pH probe removal, the sleep Quality Questionnaire will be re-administered.

Connect with a study center

  • Southern Arizona VA Health Care System

    Tucson, Arizona 85723
    United States

    Active - Recruiting

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