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

NCT ID: NCT00307944

Last Updated: 2007-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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Acid Reflux Disease Obstructive Sleep Apnea

Keywords

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Acid Reflux Obstructive Sleep Apnea Daytime Sleepiness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Principal Investigators

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David L Steward, MD

Role: PRINCIPAL_INVESTIGATOR

University Ear, Nose and Throat Specialists

Locations

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University Ear, Nose and Throat Specialists

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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04-06-24-04

Identifier Type: -

Identifier Source: org_study_id