A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia

Phase 3

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: FK199B; Drug: Zolpidem

• Registration Number: NCT00999219
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
• Patients complaining of insomnia continuously for 4 weeks or longer
• Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening
• Patient on most occasions sleeps for a total of ≥3 and <6.5 hours over the 4 week period prior to initial screening
• Patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening
• Patients have a body weight of ≥45 kg and ≤85 kg, a BMI of ≥18.5 and <30

Exclusion Criteria

• Patients with schizophrenia or manic-depressive psychosis
• Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic
• Patients with circadian rhythm sleep disorder
• Patient works night shifts
• Patients with alcoholic sleep disorder
• Patients with alcohol or drug dependence or a history of these
• Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs
• Patients with sleep apnea syndrome
• Patients with restless legs syndrome or periodic limb movement disorder
• Patients with epileptic insomnia
• Patients smoke on average 40 or more cigarettes a day
• Patients who had received psychotropic drugs other than hypnotics (including anxiolytic or antidepressant drugs for hypnotic effect) within a 4 week period prior to the initial screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FK199B-first group	FK199B	-
FK199B-first group	Zolpidem	-
Zolpidem-first group	FK199B	-
Zolpidem-first group	Zolpidem	-

Primary Outcome Measures

Name	Time	Method
Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)	8 hours

Secondary Outcome Measures

Name	Time	Method
Sleep parameters estimated from sleep questionnaire	After each night of sleep during the study period
Mean sleep parameters estimated from polysomnography recording	8 hours
Patient impression from sleep questionnaire	After each night of sleep during the study period