MedTrace Logo

Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

NCT00671125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2012-11-12

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep

Conditions

  • Chronic Insomnia

Interventions

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.

DRUG

Ramelteon

Ramelteon 16 mg, tablets, orally, once nightly for up to 5 weeks.

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • VP 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
2003-01-31
Primary Completion
2003-09-30
Completion
2003-09-30

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 NCT00671125 on ClinicalTrials.gov