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

Sleep Initiation and Maintenance Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999219
• Other study ID #: 6199-CL-0006
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2009
• Last updated: August 19, 2014
• Start date: March 2006
• Est. completion date: July 2007

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• FK199B
oral
• Zolpidem
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)		8 hours	No
Secondary	Mean sleep parameters estimated from polysomnography recording		8 hours	No
Secondary	Sleep parameters estimated from sleep questionnaire		After each night of sleep during the study period	No
Secondary	Patient impression from sleep questionnaire		After each night of sleep during the study period	No

External Links

•   Link to Results on JAPIC - enter 140535 in the JapicCTI-RNo. field