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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease

In brief

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).

Key facts

Study ID

NCT00674245

Run by

Southern Arizona VA Health Care System

People needed

40

Starts

2008-04-01

Expected to finish

2010-07-01

Last updated by the study team

2010-08-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southern Arizona VA Health Care System — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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