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Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

NCT00492011 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2012-02-28

No results posted yet for this study

Summary

The purpose of this study to determine the degree to which ramelteon, once daily (QD), can reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.

Conditions

  • Circadian Dysregulation

Interventions

DRUG

Ramelteon

Ramelteon 1 mg, tablets, orally, once nightly for 4 nights.

DRUG

Ramelteon

Ramelteon 4 mg, tablets, orally, once nightly for 4 nights.

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once nightly for 4 nights.

DRUG

Placebo

Ramelteon placebo-matching tablets, orally, once nightly for 4 nights.

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
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-08-31
Completion
2007-08-31

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 NCT00492011 on ClinicalTrials.gov