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). |
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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 |
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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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea |
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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 |
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Intervention | Drug: Pantoprazole |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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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 |
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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 ][ + ]
University Ear, Nose and Throat Specialists | Cincinnati, Ohio, United States, 45267-0528 |
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