Zolpidem Postmarketing Study in Adolescent Patients With... | NCT00432198

Studies
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

NCT00432198

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Feb 17, 2017Actual

Enrollment

122Actual

Phase

Phase 4

Conditions

Insomnia

Interventions

Zolpidem (Myslee®)
placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Feb 6, 2007

First Submission Date that Met QC Criteria

Feb 6, 2007

First Posted Date

Feb 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2017

Last Update Posted Date

Feb 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Oral	Drug: Zolpidem (Myslee®)
2	Experimental	Oral	Drug: Zolpidem (Myslee®)
3	Placebo Comparator	Oral	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zolpidem (Myslee®)	Drug	Oral	1 2	Myslee

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean daily sleep latency for double-blind period		2 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean daily total hours of sleep		2 Weeks
Mean daily frequency of intermediate awaking		2 Weeks
Mean daily time of intermediate awaking

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Label	URL
Link to results on Astellas Clinical Study Results website	View source

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077334	Zolpidem

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Chubu Region			Japan