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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:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00283946
First received: January 30, 2006
Last updated: February 25, 2009
Last verified: February 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean total sleep time during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Mean number of nightly awakenings during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Mean sleep latency during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Patient impression during the double-blind period [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00283946     History of Changes
Other Study ID Numbers: 6199-CL-0007
Study First Received: January 30, 2006
Last Updated: February 25, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders
Parasomnias
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Hypnotics and Sedatives
Zolpidem
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013