A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia

August 19, 2014 updated by: Astellas Pharma Inc

FK199B (Zolpidem MR Tablet) Phase III Clinical Study -A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia -

The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

876

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

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

16 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of nonorganic insomnia.
  • Must be able to swallow tablets

Exclusion Criteria:

  • Allergic reactions to zolpidem (Myslee)
  • Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.

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
Drug: Zolpidem MR
Oral
Active Comparator: 2
Drug: Zolpidem
Oral
Other Names:
  • Myslee

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
Safety
Time Frame: 2 Weeks
2 Weeks

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

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.

Helpful Links

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

February 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 30, 2006

First Submitted That Met QC Criteria

January 30, 2006

First Posted (Estimate)

January 31, 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

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6199-CL-0007

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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