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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.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00374777
First received: September 8, 2006
Last updated: October 20, 2009
Last verified: July 2008
History of Changes
  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 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:

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 May 16, 2013