NCT00283946

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
876

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

January 30, 2006

Last Update Submit

August 19, 2014

Conditions

Sleep Initiation and Maintenance DisordersSleep Disorders

Keywords

zolpidemsleep initiation and maintenance disorders Hypnotics and sedativesdouble-blind studycomparative study

Outcome Measures

Primary Outcomes (1)

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

    2 Weeks

Secondary Outcomes (5)

  • Mean total sleep time during the double-blind period

    2 Weeks

  • Mean number of nightly awakenings during the double-blind period

    2 Weeks

  • Mean sleep latency during the double-blind period

    2 Weeks

  • Patient impression during the double-blind period

    2 Weeks

  • Safety

    2 Weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Zolpidem MR

2

ACTIVE COMPARATOR
Drug: Zolpidem

Interventions

Zolpidem MRDRUG

Oral

1
ZolpidemDRUG

Oral

Also known as: Myslee
2

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2006

First Posted

January 31, 2006

Study Start

February 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

JP(8)