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

NCT00685269 | Completed Phase 2

• 1 other identifier: 190-028
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea Syndrome; OSAS

Outcome Measures

Primary Outcomes (1)

• AHI (frequency of apnea and hypopnea episodes).

  Nights -14, 1, 2, 8, 9

Secondary Outcomes (4)

• The mean duration of apnea and hypopnea episodes

  Nights -14, 1, 2, 8, 9

• Oxygen saturation during apnea and hypopnea

  Nights -14, 1, 2, 8, 9

• The number of arousals during apnea and hypopnea

  Nights -14, 1, 2, 8, 9

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

  Nights -14, 1, 2, 8, 9

Study Arms (2)

A

ACTIVE COMPARATOR

eszopiclone 3 mg QD

Drug: Eszopiclone

B

PLACEBO COMPARATOR

placebo tablet

Drug: Placebo

Interventions

Eszopiclone DRUG

Eszopiclone 3 mg QD

Also known as: Lunesta, (S)-Zopliclone

A

Placebo DRUG

Placebo tablet

B

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (2)

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: August 1, 2003
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (2)