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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00374777
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Drug: zolpidem MR Drug: nitrazepam Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2006
Primary Completion Date : May 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Mean wake time after sleep onset during the double-blind period [ Time Frame: 2 Weeks ]

Secondary Outcome Measures :
  1. Mean total sleep time during the double-blind period [ Time Frame: 2 Weeks ]
  2. Mean number of nightly awakenings during the double-blind period [ Time Frame: 2 Weeks ]
  3. Mean sleep latency during the double-blind period [ Time Frame: 2 Weeks ]
  4. Patient impression during the double-blind period [ Time Frame: 2 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00374777     History of Changes
Other Study ID Numbers: 6199-CL-0008
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

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