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

PHASE4CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

August 31, 2007

Study Completion Date

August 31, 2007

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.

Trial Locations (4)

Unknown

Miami

Pembroke Pines

Honolulu

New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY