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

July 24, 2015 updated by: Eurofarma Laboratorios S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • CRDB - Clinical Research & Development Brazil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Latency to persistent sleep measured by polysomnography
Time Frame: 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
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 5, 2010

First Submitted That Met QC Criteria

April 7, 2010

First Posted (Estimate)

April 8, 2010

Study Record Updates

Last Update Posted (Estimate)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 24, 2015

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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