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Completed

NCT Number: NCT00283946

A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia

The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep 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

  • Clinical diagnosis of nonorganic insomnia.
  • Must be able to swallow tablets

Exclusion criteria

  • Allergic reactions to zolpidem (Myslee)
  • Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.

Treatment and study plan

Zolpidem MR

Drug

Oral

zolpidem

Drug

Oral

Other names: Myslee

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

  5. Safety

    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, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 31, 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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