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Safety and Efficacy of Ramelteon in Healthy Subjects

NCT00671190 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2012-02-28

No results posted yet for this study

Summary

The purpose of this study is to determine the phase-advance in circadian rhythms in healthy adults subjects taking ramelteon, once daily (QD).

Conditions

  • Sleep Disorder

Interventions

DRUG

Ramelteon

Ramelteon 1 mg, tablets, orally once daily for up to 5 days

DRUG

Ramelteon

Ramelteon 2 mg, tablets, orally once daily for up to 5 days

DRUG

Ramelteon

Ramelteon 4 mg, tablets, orally once daily for up to 5 days

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally once daily for up to 5 days

DRUG

Placebo

Ramelteon placebo-matching tablets, orally once daily for up to 5 days

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
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2005-05-31
Completion
2005-05-31

Countries

  • United States

Study Locations

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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 NCT00671190 on ClinicalTrials.gov