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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00283946

Collaborator

(none)

876

Enrollment

Locations

Arms

Duration (Months)

109.5

Patients Per Site

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders Sleep Disorders	Drug: Zolpidem MR Drug: Zolpidem	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

876 participants

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 -

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Zolpidem MR Oral
Active Comparator: 2	Drug: Zolpidem Oral Other Names: Myslee

Arm

Intervention/Treatment

Experimental: 1

Drug: Zolpidem MR

Oral

Active Comparator: 2

Drug: Zolpidem

Oral

Other Names:

Myslee

Outcome Measures

Primary Outcome Measures

Mean wake time after sleep onset during the double-blind period [2 Weeks]

Secondary Outcome Measures

Mean total sleep time during the double-blind period [2 Weeks]
Mean number of nightly awakenings during the double-blind period [2 Weeks]
Mean sleep latency during the double-blind period [2 Weeks]
Patient impression during the double-blind period [2 Weeks]
Safety [2 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	Country
1	Chubu region	Japan
2	Chugoku region	Japan
3	Hokkaido region	Japan
4	Kansai region	Japan
5	Kanto region	Japan
6	Kyushu region	Japan
7	Shikoku region	Japan
8	Tohoku region	Japan