NCT01089959

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Southern Arizona VA Health Care System · Federal
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Esomeprazole	40 mg daily for 7 days
DRUG	esomeprazole	40 mg. daily, oral medication, once daily for 7 days.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-03-19
• Last updated: 2010-08-19

Locations

1 site across 1 country: United States