Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea | RxWiki

Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea

Overview[ - collapse ][ - ]

Purpose	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).
Condition	Acid Reflux Disease Obstructive Sleep Apnea
Intervention	Drug: Pantoprazole
Phase	Phase 4
Sponsor	University of Cincinnati
Responsible Party	University of Cincinnati
ClinicalTrials.gov Identifier	NCT00307944
First Received	March 27, 2006
Last Updated	December 10, 2007
Last verified	December 2007

Tracking Information[ + expand ][ + ]

First Received Date	March 27, 2006
Last Updated Date	December 10, 2007
Start Date	August 2004
Estimated Primary Completion Date	August 2006
Current Primary Outcome Measures	Difference between treatment groups with regard to change in sleepiness score (ESS)
Current Secondary Outcome Measures	Difference between treatment groups with regard to change in reaction time testing. Difference between treatment groups with regard to change in total reflux symptom scores. Difference between treatment groups with regard to change in sleep related QOL (FOSQ).

Descriptive Information[ + expand ][ + ]

Brief Title	Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
Official Title	Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing
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 either group. After two weeks, the patients will stop taking their first batch of medication to allow it to completely leave their bodies. Then the patients will begin taking the other medication so that by the end of the study, each patient will have been treated with pantoprazole for two weeks and placebo for two weeks. At the end of each two weeks, patients will be asked to complete questionnaires regarding their daytime sleepiness and reflux symptoms. Patients will also complete reaction time testing as a measure of daytime sleepiness.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Condition	Acid Reflux Disease Obstructive Sleep Apnea
Intervention	Drug: Pantoprazole
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	68
Estimated Completion Date	August 2006
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: - Age 18 or older - Daytime sleepiness (ESS >= 8) - Mild to moderate OSD (AHI<=30) - Symptoms of GERD - Symptoms of acid reflux Exclusion Criteria: - 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)
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00307944
Other Study ID Numbers	04-06-24-04
Has Data Monitoring Committee	Not Provided
Information Provided By	University of Cincinnati
Study Sponsor	University of Cincinnati
Collaborators	Wyeth is now a wholly owned subsidiary of Pfizer
Investigators	Principal Investigator: David L Steward, MD University Ear, Nose and Throat Specialists
Verification Date	December 2007

Locations[ + expand ][ + ]