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

Sleep Initiation and Maintenance Disorders Clinical Trial

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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283946
• Other study ID #: 6199-CL-0007
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2006
• Last updated: August 19, 2014
• Start date: February 2006
• Est. completion date: November 2007

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 876
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Zolpidem MR
Oral
• Zolpidem
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean wake time after sleep onset during the double-blind period		2 Weeks	No
Secondary	Mean total sleep time during the double-blind period		2 Weeks	No
Secondary	Mean number of nightly awakenings during the double-blind period		2 Weeks	No
Secondary	Mean sleep latency during the double-blind period		2 Weeks	No
Secondary	Patient impression during the double-blind period		2 Weeks	No
Secondary	Safety		2 Weeks	Yes

External Links

•   Link to Results on JAPIC - enter 140536 in the JapicCTI-RNo. field