Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

This study is currently recruiting participants.

Verified by Astellas Pharma Inc, September 2009

First Received: February 6, 2007 Last Updated: September 8, 2009 History of Changes

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00432198

Purpose

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

Condition	Intervention	Phase
Insomnia	Drug: Zolpidem (Myslee®) Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia

Resource links provided by NLM:

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Mean daily sleep latency for double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean daily total hours of sleep [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Mean daily frequency of intermediate awaking [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Mean daily time of intermediate awaking [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Impression of patient for double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	February 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Zolpidem (Myslee®) Oral
2: Experimental	Drug: Zolpidem (Myslee®) Oral
3: Placebo Comparator	Drug: placebo Oral

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432198

Contacts

Contact: Clinical Development Administration Dept

clinicaltrials_info@jp.astellas.com

Locations

Japan
	Recruiting
Kanto region, Japan
	Recruiting
Chubu region, Japan
	Recruiting
Kansai region, Japan
	Recruiting
Kyushyu region, Japan
	Recruiting
Shikoku region, Japan
	Recruiting
Hokkaido region, Japan
	Recruiting
Chugoku region, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Use Central Contact

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc. ( Director )
Study ID Numbers:	6199-JC-0001
Study First Received:	February 6, 2007
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00432198 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

Zolpidem
Adolescent
Insomnia

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Zolpidem
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Dyssomnias
Sleep Disorders

Pharmacologic Actions
Sleep Disorders, Intrinsic
Mental Disorders
Therapeutic Uses
GABA Agonists
Hypnotics and Sedatives
GABA Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010