Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
This study has been completed.
Sponsor:
University of Cincinnati
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00307944
First received: March 27, 2006
Last updated: December 10, 2007
Last verified: December 2007
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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 | Intervention | Phase |
|---|---|---|
|
Acid Reflux Disease Obstructive Sleep Apnea |
Drug: Pantoprazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing |
Resource links provided by NLM:
Further study details as provided by University of Cincinnati:
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).
| Estimated Enrollment: | 68 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | August 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307944
Locations
| United States, Ohio | |
| University Ear, Nose and Throat Specialists | |
| Cincinnati, Ohio, United States, 45267-0528 | |
Sponsors and Collaborators
University of Cincinnati
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Principal Investigator: | David L Steward, MD | University Ear, Nose and Throat Specialists |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00307944 History of Changes |
| Other Study ID Numbers: | 04-06-24-04 |
| Study First Received: | March 27, 2006 |
| Last Updated: | December 10, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Cincinnati:
|
Acid Reflux Obstructive Sleep Apnea Daytime Sleepiness |
Additional relevant MeSH terms:
|
Apnea Gastroesophageal Reflux Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Pantoprazole Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013