A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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:
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To evaluate the efficiency of eszopiclone compared to zopiclone by means of the patient's clinical history, using as secondary endpoints:
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Variables of the sleep diary of the Associação Fundo de Incentivo à Psicofarmacologia (see Appendix A), namely:
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Latency time to the beginning of the sleep;
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Frequency of night wake-ups;
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Time awake during bedtime;
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Early morning awakening;
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Total time in bed;
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Sleep efficiency;
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Sleep variables measured by actigraph;
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Insomnia Severity Index (see Appendix B);45
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Pittsburgh Sleep Quality Index (see Appendix C);46
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To evaluate the safety of eszopiclone compared to zopiclone by means of adverse events in each study arm.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: eszopiclone 3 mg Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment) |
Drug: Eszopiclone
Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
|
| Active Comparator: zopiclone 7,5mg Zopiclone 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)
|
Outcome Measures
Primary Outcome Measures
- Latency to persistent sleep measured by polysomnography [4 weeks]
Determine whether eszopiclone is noninferior to the reference drug zopiclone (Imovane®) in the treatment of insomnia. The latency to persistent sleep will be used as a primary endpoint at the end of the treatment, measured by polysomnography
Secondary Outcome Measures
- Efficiency using the variables latency time to persistent sleep, frequency of night awakenings, time awake during bedtime, early morning awakening, total time in bed, total time awake and sleep efficiency [6 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Sign the informed consent form for the study;
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Be ≥ 20 to ≥ 64 years old;
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Have diagnosis of symptomatic primary insomnia for at least 3 months;
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Have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes;
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Be able not to take any insomnia medication for 14 days before randomization to the study (washout period).
Exclusion Criteria:
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Diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study;
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Use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study;
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Use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study;
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Current use of liver metabolized medication, especially those metabolized through the cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes;
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History of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day);
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History of substance abuse or dependence;
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Patients with severe co-morbidities (at the investigator's opinion);
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Presence of liver disorders, cirrhosis or liver failure;
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Presence of psychiatric disorders diagnosed at the adult life or currently under treatment;
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Pregnant and breastfeeding women and women who want to become pregnant during the study period and who refuse to use a proper contraceptive methods during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CRDB - Clinical Research & Development Brazil | São Paulo | Brazil |
Sponsors and Collaborators
- Eurofarma Laboratorios S.A.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EF097