6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
Tracking Information | |
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First Received Date ICMJE | July 12, 2006 |
Last Updated Date | February 21, 2012 |
Start Date ICMJE | October 2003 |
Primary Completion Date | October 2004 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Average of Subjective Sleep Latency [ Time Frame: Days -14, 1, 30, 60, 90, 120, 150, 180 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00352144 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | 6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia |
Official Title ICMJE | A Six-Month, Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study |
Brief Summary | To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo. |
Detailed Description | This is a double blind, randomized (2:1; eszopiclone : placebo), placebo-controlled, multicenter, study of eszopiclone in subjects with primary insomnia. The study will involve up to 9 visits and subject participation will be approximately 224 days. After meeting all screening criteria, subjects will be randomized to either eszopiclone 3 mg QD or placebo. 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. |
Study Type ICMJE | Interventional |
Study Phase | Phase 3 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Condition ICMJE | Primary Insomnia |
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 830 |
Completion Date | October 2004 |
Primary Completion Date | October 2004 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Gender | Both |
Ages | 21 Years to 64 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00352144 |
Other Study ID Numbers ICMJE | 190-050 |
Has Data Monitoring Committee | No |
Responsible Party | Sunovion |
Study Sponsor ICMJE | Sunovion |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Sunovion |
Verification Date | February 2012 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |