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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Esomeprazole
esomeprazole
Sponsored by
Southern Arizona VA Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Acid re-flux,GERD, sleep related arousals due to GERD, Treatment of acid reflux during sleep in patients with GERD.

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Southern Arizona VA Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Esomeprazole

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2010
Last Updated
August 18, 2010
Sponsor
Southern Arizona VA Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01089959
Brief Title
Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD
Acronym
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).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Southern Arizona VA Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Acid re-flux,GERD, sleep related arousals due to GERD, Treatment of acid reflux during sleep in patients with GERD.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esomeprazole
Arm Type
Other
Arm Description
Effect of PPI esomeprazole on acid reflux & related arousals during sleep in patients with GERD.
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40 mg daily for 7 days
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40 mg. daily, oral medication, once daily for 7 days.
Primary Outcome Measure Information:
Title
The Effect of Esomeprazole 40 mg. Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients w/ GERD.
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RONNIE FASS, MD
Phone
520-792-1450
Ext
5139
Email
ronniefass@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
MARCIA R WILLIS, CCRC
Phone
520-792-1450
Ext
2032
Email
marcia.willis@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, MD
Organizational Affiliation
SAVAHCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, MD
Phone
520-792-1450
Ext
5139
Email
ronniefass@va.gov
First Name & Middle Initial & Last Name & Degree
RONNIE FASS, MD

12. IPD Sharing Statement

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

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