Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD
ISS
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).
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedAugust 19, 2010
August 1, 2010
2 years
March 18, 2010
August 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Esomeprazole
OTHEREffect of PPI esomeprazole on acid reflux \& related arousals during sleep in patients with GERD.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with Barrett's esophagus or peptic stricture on endoscopy
- Subjects with normal endoscopy and pH test
- Subjects with previous upper gastrointestinal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronnie Fass, MD
SAVAHCS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 19, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
August 19, 2010
Record last verified: 2010-08