Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS) - Full Text View

Purpose

The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.

Condition	Intervention	Phase
Obstructive Sleep Apnea Syndrome	Drug: Eszopiclone Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

AHI (frequency of apnea and hypopnea episodes). [ Time Frame: Nights -14, 1, 2, 8, 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The mean duration of apnea and hypopnea episodes [ Time Frame: Nights -14, 1, 2, 8, 9 ] [ Designated as safety issue: No ]
Oxygen saturation during apnea and hypopnea [ Time Frame: Nights -14, 1, 2, 8, 9 ] [ Designated as safety issue: No ]
The number of arousals during apnea and hypopnea [ Time Frame: Nights -14, 1, 2, 8, 9 ] [ Designated as safety issue: No ]
Objective sleep parameters as measured by PSG (i.e., latency to persistent sleep, sleep efficiency, and wake time after sleep onset [ Time Frame: Nights -14, 1, 2, 8, 9 ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	August 2003
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A eszopiclone 3 mg QD	Drug: Eszopiclone Eszopiclone 3 mg QD Other Names: Lunesta (S)-Zopliclone
Placebo Comparator: B placebo tablet	Drug: Placebo Placebo tablet

Detailed Description:

Sleep apnea is a sleep disorder characterized by pauses in breathing during sleep. This study will compare the use of eszopiclone to placebo for subjects with mild to moderate obstructive sleep Apnea syndrome (OSAS). Frequency and duration of apnea and hypopnea episodes, oxygen saturation, objective sleep parameters and safety information will be collected in this study. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility

Ages Eligible for Study:	35 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject is capable of understanding and complying with the protocol and has signed the informed consent document, including the privacy authorization. Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form.
Male and female subjects between 35 and 64 years of age, inclusive, with mild to moderate obstructive sleep apnea syndrome (AHI range ≥10 and ≤40).
Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.
Subjects must use continuous positive airway pressure (CPAP).
Subjects must be in general good health based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).

Exclusion Criteria:

Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
Subject has a history of, or current malignancy except for non melanomatous skin cancer.
Subject tests positive at screening for hepatitis B surface antigen or hepatitis C antibody, or the subject has a history of a positive result.
Subject is known to be seropositive for human immunodeficiency virus (HIV).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685269

Locations

United States, Georgia

Atlanta, Georgia, United States
United States, Ohio

Cincinnati, Ohio, United States

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00685269 History of Changes
Other Study ID Numbers:	190-028
Study First Received:	May 23, 2008
Last Updated:	February 21, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Obstructive Sleep Apnea Syndrome
OSAS

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias

Sleep Disorders
Nervous System Diseases
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013