NCT00755508 - Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia | Biotech Hunter

Enrollment

378

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

September 30, 2006

Study Completion Date

September 30, 2006

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

DRUG

Ramelteon and gabapentin

Ramelteon 4 mg, tablets, orally, once daily and gabapentin 400 mg, capsules, orally, once daily for up to one week.

DRUG

Ramelteon and gabapentin

Ramelteon 8 mg, tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.

DRUG

Gabapentin

Ramelteon placebo-matching tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.

DRUG

Placebo

Ramelteon placebo-matching tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.