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Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia

NCT01710631 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 791

Last updated 2012-10-22

No results posted yet for this study

Summary

A six-month study to determine the safety and efficacy with an additional open-label extension to determine the long-term safety of eszopiclone in the treatment of adult subjects with primary insomnia.

Conditions

  • Primary Insomnia

Interventions

DRUG

eszopiclone 3 mg

eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).

DRUG

placebo

placebo

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Lunesta Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2002-08-31
Completion
2002-08-31

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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 NCT01710631 on ClinicalTrials.gov