NCT00755495 - Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia | Biotech Hunter

Enrollment

472

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2007

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

DRUG

Ramelteon and doxepin

Ramelteon 8 mg, tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks.

DRUG

Doxepin

Ramelteon placebo-matching tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks.

DRUG

Placebo

Ramelteon placebo-matching tablets, orally, once daily and doxepin placebo-matching liquid, orally, once daily for up to five weeks.