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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. Identifier: NCT00374777
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : August 20, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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

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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
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT00374777

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Chubu region, Japan
Hokkaido region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushu region, Japan
Shikoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
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Study Chair: Use Central Contact Astellas Pharma Inc
Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00374777    
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:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
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