NCT01100164

A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia

A Phase III, Non-inferiority, Double-blind, Unicenter Clinical Trial With Two Treatment Arms - Test Group With Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.

Detailed description

The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia. To that end, the latency to persistent sleep (LPS) will be used as a primary endpoint at the end of the treatment, measured by polysomnography. The secondary objectives and endpoints of this study are as follows: * To evaluate the efficiency of eszopiclone compared to zopiclone by means of the patient's clinical history, using as secondary endpoints: * Variables of the sleep diary of the Associação Fundo de Incentivo à Psicofarmacologia (see Appendix A), namely: * Latency time to the beginning of the sleep; * Frequency of night wake-ups; * Time awake during bedtime; * Early morning awakening; * Total time in bed; * Sleep efficiency; * Sleep variables measured by actigraph; * Insomnia Severity Index (see Appendix B);45 * Pittsburgh Sleep Quality Index (see Appendix C);46 * To evaluate the safety of eszopiclone compared to zopiclone by means of adverse events in each study arm.

Conditions

• INSOMNIA

Interventions

Type	Name	Description
DRUG	Eszopiclone	Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
DRUG	Zopiclone	Zopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2010-04-08
• Last updated: 2015-07-27

Locations

1 site across 1 country: Brazil