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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283946
First Posted: January 31, 2006
Last Update Posted: August 20, 2014
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
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

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders Sleep Disorders Drug: Zolpidem MR Drug: Zolpidem Phase 3

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

Resource links provided by NLM:


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 ]

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

Enrollment: 876
Study Start Date: February 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Zolpidem MR
Oral
Active Comparator: 2 Drug: Zolpidem
Oral
Other Name: Myslee

  Eligibility

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
Criteria

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.
  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): NCT00283946


Locations
Japan
Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushu region, Japan
Shikoku region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00283946     History of Changes
Other Study ID Numbers: 6199-CL-0007
First Submitted: January 30, 2006
First Posted: January 31, 2006
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
zolpidem
sleep initiation and maintenance disorders Hypnotics and sedatives
double-blind study
comparative study

Additional relevant MeSH terms:
Disease
Sleep Wake Disorders
Parasomnias
Sleep Initiation and Maintenance Disorders
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Zolpidem
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