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

Phase 2

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: esomeprazole

• Registration Number: NCT01089959
• Lead Sponsor: Southern Arizona VA Health Care System

Brief 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-18
• Last Update Posted: 2010-08-19
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esomeprazole	esomeprazole	Effect of PPI esomeprazole on acid reflux \& related arousals during sleep in patients with GERD.

Primary Outcome Measures

Name	Time	Method
The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients w/ GERD.	2 years	This is the first study to evaluate the impact of antireflux treatment, not only on heartburn during sleep, but also on reflux-related conscious awakenings.; This has not been done previously and will thus provide an opportunity to assess the impact of esomeprazole on nighttime symptoms and awakenings.

Trial Locations

Locations (1)

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States