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Completed

NCT Number: NCT00374777

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

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

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Bipolar Disorder Bipolar and Related Disorders Dyssomnias Mental Disorders Mood Disorders Nervous System Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zolpidem MR

Drug

oral

Other names: FK199B

nitrazepam

Drug

oral

Placebo

Drug

oral

Primary outcomes

  1. Mean wake time after sleep onset during the double-blind period

    Time frame: 2 Weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2006
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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