Status:
COMPLETED
Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.
Lead Sponsor:
Southern Arizona VA Health Care System
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this research study is to determine if treatment with pantoprazole 40 mg daily versus a placebo improves sleep quality in patients with gastroesophageal reflux disease (GERD). Another p...
Detailed Description
It appears that the presence of intraesophageal stimuli alone may not be sufficient to elicit symptoms of heartburn. Most acid reflux events (\>80%-90%) do not reach conscious level and thus are not p...
Eligibility Criteria
Inclusion
- 18 to 80 yrs of age
- 2 to 3 episodes of GERD/week
- erosive esophagitis or abnormal 24 hr pH
- able to read and understand, complete questionnaires
Exclusion
- barrett's esophagus or peptic stricture on endoscopy
- normal EGD and normal 24 hour pH
- previous upper GI surgery
- comorbidity (cardiovascular, respiratory, renal, hepatic)
- use of narcotics or pain medication on regular basis
- insomnia, shift work sleep disorder, sleep apnea, restless leg syndrome
- diabetes, scleroderma or neuromuscular disorders
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00674245
Start Date
April 1 2008
End Date
July 1 2010
Last Update
August 19 2010
Active Locations (1)
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1
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723