Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.

PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 31, 2002

Primary Completion Date

July 31, 2003

Study Completion Date

July 31, 2003

Conditions
Chronic Insomnia
Interventions
DRUG

Ramelteon and Placebo (9 possible combinations total)

"Randomized sequence over two consecutive nights for a total of three treatment periods to include the following:~Ramelteon 4 mg, tablets, orally over two nights~Ramelteon 8 mg, tablets, orally over two nights~Ramelteon placebo-matching tablets, orally over two nights"

Trial Locations (18)

Unknown

Hot Springs

Irvine

Palm Springs

San Diego

Brandon

Miami

Naples

Pembroke Pines

St. Petersburg

Atlanta

Overland Park

Crestview Hills

Troy

St Louis

Winston-Salem

Cincinnati

Toledo

Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY