NCT00420810

Brief Summary

The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.

Trial Health

10
At Risk

Trial Health Score

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

Enrollment
138

participants targeted

Target at P25-P50 for phase_3

Status
terminated

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

September 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

January 5, 2007

Last Update Submit

January 13, 2015

Conditions

Primary Insomnia

Outcome Measures

Primary Outcomes (1)

  • Wake after sleep onset and Latency to persistent sleep

Secondary Outcomes (1)

  • Subjective total sleep time and subjective time to sleep onset

Interventions

MK0928 / Duration of Treatment : 8 WeeksDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Primary Insomnia
  • Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
  • Patient is willing to avoid alcohol on PSG visits
  • Patient will avoid napping during the course of the study
  • Patient's bedtime is between 9pm and 1am

You may not qualify if:

  • History of substance abuse, bipolar disorder or psychotic disorder
  • Difficulty sleeping due to other medical condition
  • History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
  • History of neoplastic malignancy within the last 5 years
  • Positive alcohol breath test during the screening visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Duration 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 11, 2007

Study Start

September 1, 2006

Primary Completion

March 1, 2007

Last Updated

January 14, 2015

Record last verified: 2015-01