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

Phase 3 Completed 263 enrolled Eurofarma Laboratorios S.A.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2011-03
Primary completion: 2012-03
Completion: 2012-04

Publications

Pinto LR Jr, Bittencourt LR, Treptow EC, Braga LR, Tufik S. Eszopiclone versus zopiclone in the treatment of insomnia. Clinics (Sao Paulo). 2016 Jan;71(1):5-9. doi: 10.6061/clinics/2016(01)02.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eszopiclone	Small molecule	3 mg	Oral
Comparator	Zopiclone	Small molecule	7.5 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications