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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Eurofarma Laboratorios S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01100164
First received: April 5, 2010
Last updated: April 7, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Insomnia
Drug: Eszopiclone
Drug: Zopiclone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • Latency to persistent sleep measured by polysomnography [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: May 2010
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100164

Locations
Brazil
CRDB - Clinical Research & Development Brazil Recruiting
São Paulo, Brazil
Contact: Sergio Tufik    55 11 5908-7082      
Principal Investigator: Sergio Tufik         
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
  More Information

No publications provided

Responsible Party: Fernanda Scalzaretto Martinez, Eurofarma Laboratorios Ltda
ClinicalTrials.gov Identifier: NCT01100164     History of Changes
Other Study ID Numbers: EF097
Study First Received: April 5, 2010
Last Updated: April 7, 2010
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by Eurofarma Laboratorios S.A.:
INSOMNIA
FOR THE TREATMENT OF INSOMNIA

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zopiclone
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014