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

NCT01100164 | Completed Phase 3 DMC

• 1 other identifier: EF097
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

INSOMNIA

Keywords

INSOMNIA; FOR THE TREATMENT OF INSOMNIA

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

eszopiclone 3 mg

EXPERIMENTAL

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

Drug: Eszopiclone

zopiclone 7,5mg

ACTIVE COMPARATOR

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

Drug: Zopiclone

Interventions

Eszopiclone DRUG

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

eszopiclone 3 mg

Zopiclone DRUG

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

zopiclone 7,5mg

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Be able not to take any insomnia medication for 14 days before randomization to the study (washout period).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

CRDB - Clinical Research & Development Brazil

São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26872077 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Eszopiclone; zopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 8, 2010
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 27, 2015

Record last verified: 2010-03

Locations

BR (1)