NCT00352144

6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

A Six-Month, Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 830 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	Eszopiclone	Eszopiclone 3 mg
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2006-07-14
• Last updated: 2012-02-22

Locations

58 sites across 1 country: United States