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Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Primary Purpose

Insomnia

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Zolpidem (Myslee®)

placebo

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Zolpidem, Adolescent

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Oral

Outcomes

Primary Outcome Measures

Mean daily sleep latency for double-blind period

Secondary Outcome Measures

Mean daily total hours of sleep

Mean daily frequency of intermediate awaking

Mean daily time of intermediate awaking

Impression of patient for double-blind period

Full Information

NCT ID

NCT00432198

First Posted

February 6, 2007

Last Updated

February 15, 2017

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00432198

Brief Title

Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

Official Title

Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

Insomnia, Zolpidem, Adolescent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Oral

Arm Title

Arm Type

Experimental

Arm Description

Oral

Arm Title

Arm Type

Placebo Comparator

Arm Description

Oral

Intervention Type

Drug

Intervention Name(s)

Zolpidem (Myslee®)

Other Intervention Name(s)

Myslee, FK199B

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Mean daily sleep latency for double-blind period

Time Frame

2 Weeks

Secondary Outcome Measure Information:

Title

Mean daily total hours of sleep

Time Frame

2 Weeks

Title

Mean daily frequency of intermediate awaking

Time Frame

2 Weeks

Title

Mean daily time of intermediate awaking

Time Frame

2 Weeks

Title

Impression of patient for double-blind period

Time Frame

2 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Use Central Contact

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Chair

Facility Information:

City

Chubu region

Country

Japan

City

Chugoku region

Country

Japan

City

Hokkaido region

Country

Japan

City

Kansai region

Country

Japan

City

Kanto region

Country

Japan

City

Kyushyu region

Country

Japan

City

Shikoku region

Country

Japan

12. IPD Sharing Statement

Links:

URL

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=140

Description

Link to results on Astellas Clinical Study Results website

Learn more about this trial

Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

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