A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00374777

Purpose

A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.

Condition	Intervention	Phase
Sleep Initiation and Maintenance Disorders	Drug: zolpidem MR Drug: nitrazepam Drug: placebo	Phase III

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:	FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Placebo- and Nitrazepam-Controlled, Group-Comparison Study in Patients With Insomnia Associated With Schizophrenia and Manic-Depressive Psychosis

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Zolpidem Nitrazepam

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 ]

Enrollment:	450
Study Start Date:	August 2006
Study Completion Date:	June 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: zolpidem MR oral Other Name: FK199B
Experimental: 2	Drug: zolpidem MR oral Other Name: FK199B
Active Comparator: 3	Drug: nitrazepam oral
Placebo Comparator: 4	Drug: placebo oral

Eligibility

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

Criteria

Inclusion Criteria:

Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.

Exclusion Criteria:

Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374777

Locations

Japan

Chubu region, Japan

Hokkaido region, Japan

Kansai region, Japan

Kanto region, Japan

Kyushu 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:	NCT00374777 History of Changes
Other Study ID Numbers:	6199-CL-0008
Study First Received:	September 8, 2006
Last Updated:	October 20, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

Insomnia
schizophrenia
manic-depressive psychosis
zolpidem

Additional relevant MeSH terms:

Bipolar Disorder
Sleep Initiation and Maintenance Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Schizophrenia and Disorders with Psychotic Features
Nitrazepam
Zolpidem
Anticonvulsants
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA-A Receptor Agonists
GABA Agonists

ClinicalTrials.gov processed this record on February 09, 2012