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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: October 13, 2009
Last updated: August 19, 2014
Last verified: August 2014
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.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: FK199B
Drug: Zolpidem
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean sleep parameters estimated from polysomnography recording [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
  • Sleep parameters estimated from sleep questionnaire [ Time Frame: After each night of sleep during the study period ] [ Designated as safety issue: No ]
  • Patient impression from sleep questionnaire [ Time Frame: After each night of sleep during the study period ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: March 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FK199B-first group Drug: FK199B
Other Name: Zolpidem MR Tablet
Drug: Zolpidem
Other Name: Myslee
Experimental: Zolpidem-first group Drug: FK199B
Other Name: Zolpidem MR Tablet
Drug: Zolpidem
Other Name: Myslee


Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00999219

Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00999219     History of Changes
Other Study ID Numbers: 6199-CL-0006 
Study First Received: October 13, 2009
Last Updated: August 19, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Agonists
GABA-A Receptor Agonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016