NCT00095069

Brief Summary

The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2004

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

October 1, 2004

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

2.3 years

First QC Date

October 29, 2004

Last Update Submit

January 13, 2015

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Patient-reported amount of sleep and time to fall sleep at night after three months

Secondary Outcomes (3)

  • Patient-reported awakenings at night

  • Sleep quality

  • Functioning after 3 months

Interventions

MK0928, gaboxadol / Duration of Treatment - 1 yearDRUG
Comparator: placebo / Duration of Treatment -1 yearDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of insomnia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Roth T, Lines C, Vandormael K, Ceesay P, Anderson D, Snavely D. Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. J Clin Sleep Med. 2010 Feb 15;6(1):30-9.

    PMID: 20191935DERIVED

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

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

October 29, 2004

First Posted

November 1, 2004

Study Start

October 1, 2004

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 14, 2015

Record last verified: 2015-01