Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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 purpose is to determine if treatment with pantoprazole 40 mg once daily versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease using spectral analysis of sleep electroencephalogram (EEG).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Southern Arizona VA Health Care System
• Treatments: Pantoprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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