NCT00102154

Brief Summary

A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

January 1, 2005

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2005

Completed
Last Updated

January 14, 2015

Status Verified

August 1, 2014

First QC Date

January 21, 2005

Last Update Submit

January 13, 2015

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • 4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability

Secondary Outcomes (1)

  • Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)

Interventions

MK0928, gaboxadol / Duration of Treatment: 10 monthsDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults who are between the ages of 18 and 64

You may not qualify if:

  • Adults who are diagnosed with insomnia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

gaboxadolDuration of Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2005

First Posted

January 24, 2005

Study Start

January 1, 2005

Last Updated

January 14, 2015

Record last verified: 2014-08