Back to resultsStudy of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
Primary Purpose
Acid Reflux Disease, Obstructive Sleep Apnea
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pantoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Acid Reflux Disease focused on measuring Acid Reflux, Obstructive Sleep Apnea, Daytime Sleepiness
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)
Sites / Locations
- University Ear, Nose and Throat Specialists
Outcomes
Primary Outcome Measures
Difference between treatment groups with regard to change in sleepiness score (ESS)
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).
Full Information
NCT ID
NCT00307944
First Posted
March 27, 2006
Last Updated
December 10, 2007
Sponsor
University of Cincinnati
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00307944
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cincinnati
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acid Reflux Disease, Obstructive Sleep Apnea
Keywords
Acid Reflux, Obstructive Sleep Apnea, Daytime Sleepiness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
68 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Primary Outcome Measure Information:
Title
Difference between treatment groups with regard to change in sleepiness score (ESS)
Secondary Outcome Measure Information:
Title
Difference between treatment groups with regard to change in reaction time testing.
Title
Difference between treatment groups with regard to change in total reflux symptom scores.
Title
Difference between treatment groups with regard to change in sleep related QOL (FOSQ).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Steward, MD
Organizational Affiliation
University Ear, Nose and Throat Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Ear, Nose and Throat Specialists
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0528
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
We'll reach out to this number within 24 hrs