NCT00432198

Brief Summary

To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2007

Typical duration for phase_4

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

February 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

2.9 years

First QC Date

February 6, 2007

Last Update Submit

February 15, 2017

Conditions

Insomnia

Keywords

InsomniaZolpidemAdolescent

Outcome Measures

Primary Outcomes (1)

  • Mean daily sleep latency for double-blind period

    2 Weeks

Secondary Outcomes (4)

  • Mean daily total hours of sleep

    2 Weeks

  • Mean daily frequency of intermediate awaking

    2 Weeks

  • Mean daily time of intermediate awaking

    2 Weeks

  • Impression of patient for double-blind period

    2 Weeks

Study Arms (3)

1

EXPERIMENTAL

Oral

Drug: Zolpidem (Myslee®)

2

EXPERIMENTAL

Oral

Drug: Zolpidem (Myslee®)

3

PLACEBO COMPARATOR

Oral

Drug: placebo

Interventions

Zolpidem (Myslee®)DRUG

Oral

Also known as: Myslee, FK199B
12
placeboDRUG

Oral

3

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10
  • patients whose age at the time of obtaining consent is 12 years or over and 18 years or below

You may not qualify if:

  • patients with schizophrenia or manic-depressive illness
  • patients with insomnia caused by physical diseases
  • patients having a history of hypersensitivity to zolpidem
  • patients with attention-deficit hyperactivity disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushyu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Related Links

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 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2007

First Posted

February 7, 2007

Study Start

February 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

JP(7)