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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

NCT01100164 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2015-07-27

No results posted yet for this study

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

Interventions

DRUG

Eszopiclone

Eszopiclone - 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)

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-03-31
Completion
2012-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01100164 on ClinicalTrials.gov