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Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia

NCT00237497 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2012-02-02

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), compared to placebo with Zopiclone in adults with chronic insomnia

Conditions

  • Balance

Interventions

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once daily for up to 28 nights.

DRUG

Zopiclone

Zopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights.

DRUG

Placebo

Placebo-matching tablets, orally, once daily for up to 28 nights.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda Global Research & Development Centre (Europe)

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
2005-07-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT00237497 on ClinicalTrials.gov