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

August 19, 2014 updated by: Astellas Pharma Inc

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyushu, Japan
      • Shikoku, Japan
      • Touhoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)
Time Frame: 8 hours
8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean sleep parameters estimated from polysomnography recording
Time Frame: 8 hours
8 hours
Sleep parameters estimated from sleep questionnaire
Time Frame: After each night of sleep during the study period
After each night of sleep during the study period
Patient impression from sleep questionnaire
Time Frame: After each night of sleep during the study period
After each night of sleep during the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (Estimate)

October 21, 2009

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6199-CL-0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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