Status:
COMPLETED
Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Acid Reflux Disease
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if using Pantoprazole decreases your daytime sleepiness and improves your reaction time when compared to using a placebo (sugar pill).
Detailed Description
Half of the patients enrolled in the study will begin the study taking Pantoprazole. The other half will begin the study taking a placebo (sugar pill). There is an equal chance of being placed in eith...
Eligibility Criteria
Inclusion
- Age 18 or older
- Daytime sleepiness (ESS \>= 8)
- Mild to moderate OSD (AHI\<=30)
- Symptoms of GERD
- Symptoms of acid reflux
Exclusion
- Pregnant or trying to become pregnant
- Depression or unstable psychiatric disorder
- Allergy to Pantoprazole
- Taking a proton pump inhibitor within the last month
- Taking a histamine-2 receptor blocker within the last month
- Automobile or industrial accident due to daytime sleepiness
- Currently taking ketoconazole, itraconazole, ampicillin or iron salts
- Hypersecretory acid disorder (Zollinger-Ellison Syndrome)
- Active peptic ulcer disease
- Severe concomitant disease of another major body system
- Malignancy in the past 5 years
- Current abuse of alcohol, medication or drugs
- Sedative medications
- Additional treatment for obstructive sleep apnea (i.e. CPAP or surgery)
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00307944
Start Date
August 1 2004
End Date
August 1 2006
Last Update
December 12 2007
Active Locations (1)
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1
University Ear, Nose and Throat Specialists
Cincinnati, Ohio, United States, 45267-0528