Zolpidem Postmarketing Study in Adolescent Patients With Insomnia - Full Text View

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 ]

Enrollment:	122
Study Start Date:	February 2007
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Zolpidem (Myslee®) Oral Other Names: Myslee FK199B
Experimental: 2	Drug: Zolpidem (Myslee®) Oral Other Names: Myslee FK199B
Placebo Comparator: 3	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

Locations

Japan

Chubu region, Japan

Chugoku region, Japan

Hokkaido region, Japan

Kansai region, Japan

Kanto region, Japan

Kyushyu region, Japan

Shikoku region, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Use Central Contact

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00432198 History of Changes
Other Study ID Numbers:	6199-JC-0001
Study First Received:	February 6, 2007
Last Updated:	March 3, 2010
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
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012