MedTrace Logo

Efficacy of Ramelteon on Transient Insomnia in Healthy Adults

NCT00671398 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2012-02-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.

Conditions

  • Transient Insomnia

Interventions

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally for one night only.

DRUG

Ramelteon

Ramelteon 16 mg, tablets, orally for one night only

DRUG

Placebo

Ramelteon placebo-matching tablets, orally for one night only

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
Yes

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2003-05-31
Completion
2003-05-31

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 NCT00671398 on ClinicalTrials.gov