Clinical trial NCT00999219: A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia
Official title: FK199B (Zolpidem MR Tablet) Phase III Clinical Study - A Double-Blind, Crossover, Comparative Polysomnographic Study Using Zolpidem (Myslee®) as a Positive Control in Patients With Insomnia, Excluding Patients With Schizophrenia or Manic-Depressive Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: FK199B
Zolpidem
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-10-21
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)
timeFrame: 8 hours
Secondary outcomes:
measure: Mean sleep parameters estimated from polysomnography recording
timeFrame: 8 hours
measure: Sleep parameters estimated from sleep questionnaire
timeFrame: After each night of sleep during the study period
measure: Patient impression from sleep questionnaire
timeFrame: After each night of sleep during the study period
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: