Back to results

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

Primary Purpose

INSOMNIA

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Eszopiclone

Zopiclone

About this trial

This is an interventional treatment trial for INSOMNIA focused on measuring INSOMNIA, FOR THE TREATMENT OF INSOMNIA

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CRDB - Clinical Research & Development Brazil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

eszopiclone 3 mg

zopiclone 7,5mg

Arm Description

Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)

Zopiclone once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)

Outcomes

Primary Outcome Measures

Latency to persistent sleep measured by polysomnography

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

Full Information

NCT ID

NCT01100164

First Posted

April 5, 2010

Last Updated

July 24, 2015

Sponsor

Eurofarma Laboratorios S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01100164

Brief Title

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

Acronym

Eszo

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 Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

INSOMNIA

Keywords

INSOMNIA, FOR THE TREATMENT OF INSOMNIA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

263 (Actual)

8. Arms, Groups, and Interventions

Arm Title

eszopiclone 3 mg

Arm Type

Experimental

Arm Description

Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)

Arm Title

zopiclone 7,5mg

Arm Type

Active Comparator

Arm Description

Zopiclone once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)

Intervention Type

Drug

Intervention Name(s)

Eszopiclone

Intervention Description

Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)

Intervention Type

Drug

Intervention Name(s)

Zopiclone

Intervention Description

Zopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)

Primary Outcome Measure Information:

Title

Latency to persistent sleep measured by polysomnography

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

CRDB - Clinical Research & Development Brazil

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

26872077

Citation

Pinto LR Jr, Bittencourt LR, Treptow EC, Braga LR, Tufik S. Eszopiclone versus zopiclone in the treatment of insomnia. Clinics (Sao Paulo). 2016 Jan;71(1):5-9. doi: 10.6061/clinics/2016(01)02.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs