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

2014-08-27 03:14:44 | BioPortfolio

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.

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

Conditions

Insomnia

Intervention

Eszopiclone, Zopiclone

Location

CRDB - Clinical Research & Development Brazil
São Paulo
Brazil

Status

Not yet recruiting

Source

Eurofarma Laboratorios Ltda

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:44-0400

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