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Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

NCT00247390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2010-06-03

No results posted yet for this study

Summary

The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).

Conditions

  • Chronic Insomnia

Interventions

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once daily for up to 42 weeks.

DRUG

Placebo

Ramelteon placebo-matching tablets, orally, once daily for up to 42 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • Finland
  • France
  • Germany
  • Italy
  • Russia

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 NCT00247390 on ClinicalTrials.gov