Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea - Full Text View

Sponsor:	University of Cincinnati
Collaborator:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00307944

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 IV

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:

MedlinePlus related topics: GERD Sleep Apnea

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

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

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.

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 February 09, 2012