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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00999219
First received: October 13, 2009
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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
oral
Other Name: Zolpidem MR Tablet
Drug: Zolpidem
oral
Other Name: Myslee
Experimental: Zolpidem-first group Drug: FK199B
oral
Other Name: Zolpidem MR Tablet
Drug: Zolpidem
oral
Other Name: Myslee

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999219

Locations
Japan
Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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:
FK199B
Zolpidem

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

ClinicalTrials.gov processed this record on October 19, 2014