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

Astellas Pharma Inc450 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

450

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

zolpidem MRDRUG

oral

nitrazepamDRUG

oral

placeboDRUG

oral

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (6)

Unnamed facility

Chubu Region, Japan

Unnamed facility

Hokkaido Region, Japan

Unnamed facility

Kansai Region, Japan

Unnamed facility

Kanto Region, Japan

Unnamed facility

Kyushu Region, Japan

Outcomes

Primary Outcomes

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

Time frame: 2 Weeks

Secondary Outcomes

Mean total sleep time during the double-blind period

Time frame: 2 Weeks

Mean number of nightly awakenings during the double-blind period

Time frame: 2 Weeks

Mean sleep latency during the double-blind period

Time frame: 2 Weeks

Patient impression during the double-blind period

Time frame: 2 Weeks

Data from ClinicalTrials.gov

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