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

August 19, 2014 updated by: Astellas Pharma Inc

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

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chubu region, Japan
      • Hokkaido region, Japan
      • Kansai region, Japan
      • Kanto region, Japan
      • Kyushu region, Japan
      • Shikoku region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
oral
Other Names:
  • FK199B
Experimental: 2
oral
Other Names:
  • FK199B
Placebo Comparator: 4
oral
Active Comparator: 3
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean wake time after sleep onset during the double-blind period
Time Frame: 2 Weeks
2 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean total sleep time during the double-blind period
Time Frame: 2 Weeks
2 Weeks
Mean number of nightly awakenings during the double-blind period
Time Frame: 2 Weeks
2 Weeks
Mean sleep latency during the double-blind period
Time Frame: 2 Weeks
2 Weeks
Patient impression during the double-blind period
Time Frame: 2 Weeks
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 8, 2006

First Submitted That Met QC Criteria

September 8, 2006

First Posted (Estimate)

September 11, 2006

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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