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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00685269
First received: May 23, 2008
Last updated: February 21, 2012
Last verified: February 2012

May 23, 2008
February 21, 2012
August 2003
January 2004   (final data collection date for primary outcome measure)
AHI (frequency of apnea and hypopnea episodes). [ Time Frame: Nights -14, 1, 2, 8, 9 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00685269 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
The Safety and Efficacy of Eszopiclone in Subjects With Mild to Moderate Obstructive Sleep Apnea Syndrome

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obstructive Sleep Apnea Syndrome
  • Drug: Eszopiclone
    Eszopiclone 3 mg QD
    Other Names:
    • Lunesta
    • (S)-Zopliclone
  • Drug: Placebo
    Placebo tablet
  • Active Comparator: A
    eszopiclone 3 mg QD
    Intervention: Drug: Eszopiclone
  • Placebo Comparator: B
    placebo tablet
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2004
January 2004   (final data collection date for primary outcome measure)

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).
Both
35 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00685269
190-028
No
Sunovion
Sunovion
Not Provided
Not Provided
Sunovion
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP