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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Eszopiclone

Placebo

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive Sleep Apnea Syndrome, OSAS

Eligibility Criteria

35 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

eszopiclone 3 mg QD

placebo tablet

Outcomes

Primary Outcome Measures

AHI (frequency of apnea and hypopnea episodes).

Secondary Outcome Measures

The mean duration of apnea and hypopnea episodes

Oxygen saturation during apnea and hypopnea

The number of arousals during apnea and hypopnea

Objective sleep parameters as measured by PSG (i.e., latency to persistent sleep, sleep efficiency, and wake time after sleep onset

Full Information

NCT ID

NCT00685269

First Posted

May 23, 2008

Last Updated

February 21, 2012

Sponsor

Sumitomo Pharma America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00685269

Brief Title

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

Official Title

The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

January 2004 (Actual)

Study Completion Date

January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea Syndrome, OSAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

eszopiclone 3 mg QD

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo tablet

Intervention Type

Drug

Intervention Name(s)

Eszopiclone

Other Intervention Name(s)

Lunesta, (S)-Zopliclone

Intervention Description

Eszopiclone 3 mg QD

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet

Primary Outcome Measure Information:

Title

AHI (frequency of apnea and hypopnea episodes).

Time Frame

Nights -14, 1, 2, 8, 9

Secondary Outcome Measure Information:

Title

The mean duration of apnea and hypopnea episodes

Time Frame

Nights -14, 1, 2, 8, 9

Title

Oxygen saturation during apnea and hypopnea

Time Frame

Nights -14, 1, 2, 8, 9

Title

The number of arousals during apnea and hypopnea

Time Frame

Nights -14, 1, 2, 8, 9

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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).

Facility Information:

City

Atlanta

State/Province

Georgia

Country

United States

City

Cincinnati

State/Province

Ohio

Country

United States

12. IPD Sharing Statement

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

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