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Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia

NCT00756002 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2010-06-02

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of 4 mg of Ramelteon, once daily (QD), in subjects with chronic insomnia.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

Ramelteon

Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.

DRUG

Placebo

Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-03-31
Completion
2008-03-31

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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 NCT00756002 on ClinicalTrials.gov