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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Southern Arizona VA Health Care System.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089959
First Posted: March 19, 2010
Last Update Posted: August 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Southern Arizona VA Health Care System
  Purpose
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.

Condition Intervention Phase
Gastroesophageal Reflux Disease Drug: Esomeprazole Drug: esomeprazole Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Southern Arizona VA Health Care System:

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. [ Time Frame: 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.



Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Esomeprazole
Effect of PPI esomeprazole on acid reflux & related arousals during sleep in patients with GERD.
Drug: Esomeprazole
40 mg daily for 7 days
Other Name: Nexium
Drug: esomeprazole
40 mg. daily, oral medication, once daily for 7 days.
Other Name: Nexium

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089959


Contacts
Contact: RONNIE FASS, MD 520-792-1450 ext 5139 ronniefass@va.gov
Contact: MARCIA R WILLIS, CCRC 520-792-1450 ext 2032 marcia.willis@va.gov

Locations
United States, Arizona
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
Contact: Ronnie Fass, MD    520-792-1450 ext 5139    ronniefass@va.gov   
Principal Investigator: RONNIE FASS, MD         
Sponsors and Collaborators
Southern Arizona VA Health Care System
Investigators
Principal Investigator: Ronnie Fass, MD SAVAHCS
  More Information

Responsible Party: RONNIE FASS M.D., SOUTHERN AZ. VA HEALTH CARE SYSTEM
ClinicalTrials.gov Identifier: NCT01089959     History of Changes
Other Study ID Numbers: ISS Astra Zeneca 7 day Nexium
First Submitted: March 18, 2010
First Posted: March 19, 2010
Last Update Posted: August 19, 2010
Last Verified: August 2010

Keywords provided by Southern Arizona VA Health Care System:
Acid re-flux,GERD
sleep related arousals due to GERD
Treatment of acid reflux during sleep in patients with GERD.

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action