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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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
CRDB - Clinical Research & Development Brazil
Not yet recruiting
Eurofarma Laboratorios Ltda
Published on BioPortfolio: 2014-08-27T03:14:44-0400
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