NCT00653562

Brief Summary

To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2006

Typical duration for phase_4

Geographic Reach
1 country

4 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

November 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

3.3 years

First QC Date

April 2, 2008

Last Update Submit

February 15, 2017

Conditions

InsomniaSleep Initiation and Maintenance Disorders

Keywords

polysomnographyzolpidemSleep disordersadolescent

Outcome Measures

Primary Outcomes (1)

  • Sleep latency

    2 days

Secondary Outcomes (4)

  • Total hours of sleep

    2 days

  • Frequency of intermediate awaking

    2 days

  • Time of intermediate awaking

    2 days

  • Patient impression

    2 days

Study Arms (1)

1

EXPERIMENTAL

Patients will receive placebo in one part and zolpidem in the other part

Drug: zolpidem

Interventions

zolpidemDRUG

Oral

Also known as: Myslee
1

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

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 (4)

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 7, 2008

Study Start

November 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

JP(4)