Status:
COMPLETED
A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00999219
Start Date
March 1 2006
End Date
July 1 2007
Last Update
August 20 2014
Active Locations (7)
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1
Chūbu, Japan
2
Hokkaido, Japan
3
Kansai, Japan
4
Kantou, Japan