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

Condition(s) targeted: Insomnia; Schizophrenia; Manic-Depressive Psychosis

Intervention: zolpidem MR (Drug); nitrazepam (Drug); placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

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

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Mean wake time after sleep onset during the double-blind period

Secondary outcome:

Mean total sleep time during the double-blind period

Mean number of nightly awakenings during the double-blind period

Mean sleep latency during the double-blind period

Patient impression during the double-blind period

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

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.

Hokkaido region, Japan

Kanto region, Japan

Chubu region, Japan

Kansai region, Japan

Shikoku region, Japan

Kyushu region, Japan

Starting date: August 2006
Ending date: March 2008
Last updated: January 16, 2008