A Double-Blind, Group-Comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00283946

Purpose

The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug

Condition	Intervention	Phase
Sleep Initiation and Maintenance Disorders Sleep Disorders	Drug: Zolpidem MR Drug: Zolpidem	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Group-Comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Mean wake time after sleep onset during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean total sleep time during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Mean number of nightly awakenings during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Mean sleep latency during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Patient impression during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Safety [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	876
Study Start Date:	February 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Zolpidem MR Oral
2: Active Comparator	Drug: Zolpidem Oral

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of nonorganic insomnia.
Must be able to swallow tablets

Exclusion Criteria:

Allergic reactions to zolpidem (Myslee)
Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283946

Locations

Japan

Hokkaido region, Japan

Tohoku region, Japan

Kanto region, Japan

Chubu region, Japan

Kyushu region, Japan

Chugoku region, Japan

Shikoku region, Japan

Kansai region, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma Inc. ( Director )
Study ID Numbers:	6199-CL-0007
Study First Received:	January 30, 2006
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00283946 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

zolpidem
sleep initiation and maintenance disorders Hypnotics and sedatives
double-blind study
comparative study

Additional relevant MeSH terms:

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

Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Therapeutic Uses
GABA Agonists
Hypnotics and Sedatives
Neurologic Manifestations
GABA Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010