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Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.

NCT00414102 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2016-06-28

No results posted yet for this study

Summary

The purpose of this study is to determine the subjective treatment effects of ramelteon, once daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in adults with chronic insomnia.

Conditions

  • Chronic Insomnia

Interventions

DRUG

Ramelteon

Ramelteon 8mg, tablets, orally, once nightly for up to 28 days.

DRUG

Placebo

Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda Global Research & Development Center

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
2006-10-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00414102 on ClinicalTrials.gov