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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: September 8, 2006
Last updated: August 19, 2014
Last verified: August 2014
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 3

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:

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
Other Name: FK199B
Experimental: 2 Drug: zolpidem MR
Other Name: FK199B
Active Comparator: 3 Drug: nitrazepam
Placebo Comparator: 4 Drug: placebo


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

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.
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Please refer to this study by its identifier: NCT00374777

Chubu region, Japan
Hokkaido region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushu region, Japan
Shikoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00374777     History of Changes
Other Study ID Numbers: 6199-CL-0008 
Study First Received: September 8, 2006
Last Updated: August 19, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
manic-depressive psychosis

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Bipolar Disorder
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Bipolar and Related Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators processed this record on October 21, 2016