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

Gastroesophageal Reflux Disease Clinical Trial

— ISS  

Official title:

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01089959
• Other study ID #: ISS Astra Zeneca 7 day Nexium
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 18, 2010
• Last updated: August 18, 2010
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: August 2010
• Source: Southern Arizona VA Health Care System
• Contact: RONNIE FASS, MD
• Phone: 520-792-1450
• Email: ronniefass[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Esomeprazole
40 mg daily for 7 days
• esomeprazole
40 mg. daily, oral medication, once daily for 7 days.

Locations

Country	Name	City	State
United States	Southern Arizona VA Health Care System	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Southern Arizona VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients w/ GERD.	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.	2 years	No