NCT00374777

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

6 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

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

1.8 years

First QC Date

September 8, 2006

Last Update Submit

August 19, 2014

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Insomniaschizophreniamanic-depressive psychosiszolpidem

Outcome Measures

Primary Outcomes (1)

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

    2 Weeks

Secondary Outcomes (4)

  • 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

Study Arms (4)

1

EXPERIMENTAL
Drug: zolpidem MR

2

EXPERIMENTAL
Drug: zolpidem MR

3

ACTIVE COMPARATOR
Drug: nitrazepam

4

PLACEBO COMPARATOR
Drug: placebo

Interventions

zolpidem MRDRUG

oral

Also known as: FK199B
12
nitrazepamDRUG

oral

3
placeboDRUG

oral

4

Eligibility Criteria

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

You may qualify if:

  • Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.

You may not qualify if:

  • Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Chubu 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

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSchizophreniaBipolar Disorder

Interventions

Nitrazepam

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Use 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

September 8, 2006

First Posted

September 11, 2006

Study Start

August 1, 2006

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

JP(6)