NCT00999219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

October 13, 2009

Last Update Submit

August 19, 2014

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

FK199BZolpidem

Outcome Measures

Primary Outcomes (1)

  • Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)

    8 hours

Secondary Outcomes (3)

  • Mean sleep parameters estimated from polysomnography recording

    8 hours

  • Sleep parameters estimated from sleep questionnaire

    After each night of sleep during the study period

  • Patient impression from sleep questionnaire

    After each night of sleep during the study period

Study Arms (2)

FK199B-first group

EXPERIMENTAL
Drug: FK199BDrug: Zolpidem

Zolpidem-first group

EXPERIMENTAL
Drug: FK199BDrug: Zolpidem

Interventions

FK199BDRUG

oral

Also known as: Zolpidem MR Tablet
FK199B-first groupZolpidem-first group
ZolpidemDRUG

oral

Also known as: Myslee
FK199B-first groupZolpidem-first group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 21, 2009

Study Start

March 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

JP(7)