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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

• Drug: FK199B
  • oral
• Drug: Zolpidem
  • oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: FK199B-first group
• Experimental: Zolpidem-first group

Primary Measures

• Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)
  • Time Frame: 8 hours
    Safety Issue?: No

Secondary Measures

• Mean sleep parameters estimated from polysomnography recording
  • Time Frame: 8 hours
    Safety Issue?: No
• Sleep parameters estimated from sleep questionnaire
  • Time Frame: After each night of sleep during the study period
    Safety Issue?: No
• Patient impression from sleep questionnaire
  • Time Frame: After each night of sleep during the study period
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Chair Astellas Pharma Inc  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00999219

Study ID Number: 6199-CL-0006

ClinicalTrials.gov Identifier: NCT00999219

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Link to Results on ClinicalStudiesResults.org