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

Southern Arizona VA Health Care System

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Esomeprazole; Drug: esomeprazole

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01089959

ISS Astra Zeneca 7 day Nexium

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Esomeprazole

Other group

Description:

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

Treatment:

Drug: Esomeprazole