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

NCT ID: NCT00374777

Last Updated: 2014-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

zolpidem MR

Intervention Type DRUG

oral

2

Group Type EXPERIMENTAL

zolpidem MR

Intervention Type DRUG

oral

3

Group Type ACTIVE_COMPARATOR

nitrazepam

Intervention Type DRUG

oral

4

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral

Interventions

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zolpidem MR

oral

Intervention Type DRUG

nitrazepam

oral

Intervention Type DRUG

placebo

oral

Intervention Type DRUG

Other Intervention Names

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FK199B

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Chubu Region, , Japan

Site Status

Hokkaido Region, , Japan

Site Status

Kansai Region, , Japan

Site Status

Kanto Region, , Japan

Site Status

Kyushu Region, , Japan

Site Status

Shikoku Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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6199-CL-0008

Identifier Type: -

Identifier Source: org_study_id

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