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Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

NCT00593736 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2012-02-28

Study results available
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Summary

The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.

Conditions

  • Sleep Disorders, Circadian Rhythm

Interventions

DRUG

Ramelteon

Ramelteon 1 mg, tablets, orally, once daily for up to two weeks.

DRUG

Ramelteon

Ramelteon 4 mg, tablets, orally, once daily for up to two weeks.

DRUG

Ramelteon

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

DRUG

Placebo

Ramelteon placebo-matching tablets, orally, once daily for up to two weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-05-31
Completion
2008-05-31

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 NCT00593736 on ClinicalTrials.gov