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 because the information has not been verified recently.
Verified August 2010 by Southern Arizona VA Health Care System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier:
NCT01089959
First received: March 18, 2010
Last updated: August 18, 2010
Last verified: August 2010

March 18, 2010
August 18, 2010
March 2010
March 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01089959 on ClinicalTrials.gov Archive Site
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Not Provided
Not Provided
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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
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).

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.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • 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
Esomeprazole
Effect of PPI esomeprazole on acid reflux & related arousals during sleep in patients with GERD.
Interventions:
  • Drug: Esomeprazole
  • Drug: esomeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
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
United States
 
NCT01089959
ISS Astra Zeneca 7 day Nexium
No
RONNIE FASS M.D., SOUTHERN AZ. VA HEALTH CARE SYSTEM
Southern Arizona VA Health Care System
Not Provided
Principal Investigator: Ronnie Fass, MD SAVAHCS
Southern Arizona VA Health Care System
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP