Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: Zolpidem (Myslee®) (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
Overall contact:
Clinical Development Administration Dept, Email: clinicaltrials_info@jp.astellas.com
Summary
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized
double blind-controlled trial
Clinical Details
Official title: Zolpidem Postmarketing Clinical Study: A Double Blind, Placebo Controlled Group Comparative Trial in the Adolescent Patients With Insomnia
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Mean daily sleep latency for double-blind period
Secondary outcome: Mean daily total hours of sleepMean daily frequency of intermediate awaking Mean daily time of intermediate awaking Impression of patient for double-blind period
Eligibility
Minimum age: 12 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Clinical Development Administration Dept, Email: clinicaltrials_info@jp.astellas.com
Kanto region, Japan; Recruiting
Chubu region, Japan; Recruiting
Kansai region, Japan; Recruiting
Chugoku region, Japan; Recruiting
Shikoku region, Japan; Recruiting
Hokkaido region, Japan; Recruiting
Kyushyu region, Japan; Recruiting
Additional Information
Starting date: February 2007
Ending date: January 2010
Last updated: September 8, 2009
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