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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

Information source: Eurofarma Laboratorios S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: INSOMNIA

Intervention: Eszopiclone (Drug); Zopiclone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eurofarma Laboratorios S.A.

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 Details

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

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

Primary outcome: Latency to persistent sleep measured by polysomnography

Secondary outcome: 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

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:

- 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.

Eligibility

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Sign the informed consent form for the study;

- Be ≥ 20 to ≥ 64 years old;

- Have diagnosis of symptomatic primary insomnia for at least 3 months;

- 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;

- Be able not to take any insomnia medication for 14 days before randomization to the

study (washout period). Exclusion Criteria:

- Diagnosis of other sleep disorder by polysomnography conducted 90 days before the

inclusion in the study;

- 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;

- Use of any herbal supplement for insomnia or melatonin during the 14 days before

entering the study;

- Current use of liver metabolized medication, especially those metabolized through the

cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes;

- 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);

- History of substance abuse or dependence;

- Patients with severe co-morbidities (at the investigator's opinion);

- Presence of liver disorders, cirrhosis or liver failure;

- Presence of psychiatric disorders diagnosed at the adult life or currently under

treatment;

- 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.

Locations and Contacts

CRDB - Clinical Research & Development Brazil, São Paulo, Brazil
Additional Information

Starting date: March 2011
Last updated: July 24, 2015

Page last updated: August 23, 2015

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