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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00999219
Collaborator
(none)
55
Enrollment
7
Locations
2
Arms
16
Duration (Months)
7.9
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: FK199B-first group

Drug: FK199B
oral
Other Names:
  • Zolpidem MR Tablet

    • Drug: Zolpidem
    oral
    Other Names:
  • Myslee

    		•
    Experimental: Zolpidem-first group

    Drug: FK199B
    oral
    Other Names:
  • Zolpidem MR Tablet

    • Drug: Zolpidem
    oral
    Other Names:
  • Myslee

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings) [8 hours]

    Secondary Outcome Measures

    1. Mean sleep parameters estimated from polysomnography recording [8 hours]

    2. Sleep parameters estimated from sleep questionnaire [After each night of sleep during the study period]

    3. Patient impression from sleep questionnaire [After each night of sleep during the study period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chubu Japan
    2 Hokkaido Japan
    3 Kansai Japan
    4 Kantou Japan
    5 Kyushu Japan
    6 Shikoku Japan
    7 Touhoku Japan

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT00999219
    Other Study ID Numbers:
    • 6199-CL-0006
    First Posted:
    Oct 21, 2009
    Last Update Posted:
    Aug 20, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by Astellas Pharma Inc
    FK199B
    Zolpidem
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Zolpidem

    Study Results

    No Results Posted as of Aug 20, 2014