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

INSOMNIA Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• INSOMNIA

• NCT number: NCT01100164
• Study type: Interventional
• Source: Eurofarma Laboratorios S.A.
• Status: Completed
• Phase: Phase 3
• Start date: March 2011
• Completion date: April 2012