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A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients

FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-Blind, Placebo- and Nitrazepam-Controlled, Group-Comparison Study in Patients With Insomnia Associated With Schizophrenia and Manic-Depressive Psychosis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00374777
Enrollment
450
Registered
2006-09-11
Start date
2006-08-31
Completion date
2008-06-30
Last updated
2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Insomnia, schizophrenia, manic-depressive psychosis, zolpidem

Brief summary

A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.

Interventions

DRUGzolpidem MR

oral

DRUGnitrazepam

oral

DRUGplacebo

oral

Sponsors

Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.

Exclusion criteria

* Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.

Design outcomes

Primary

MeasureTime frame
Mean wake time after sleep onset during the double-blind period2 Weeks

Secondary

MeasureTime frame
Mean total sleep time during the double-blind period2 Weeks
Mean number of nightly awakenings during the double-blind period2 Weeks
Mean sleep latency during the double-blind period2 Weeks
Patient impression during the double-blind period2 Weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026