NCT00266357

Brief Summary

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.

Trial Health

10
At Risk

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

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

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2005

Completed
1.2 years 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

1.3 years

First QC Date

December 14, 2005

Last Update Submit

January 13, 2015

Conditions

Primary Insomnia

Outcome Measures

Primary Outcomes (1)

  • Mean of total sleep time over 2 nights.

Secondary Outcomes (1)

  • Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.

Interventions

MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)DRUG
Placebo / Duration of Treatment: 2 days for screening periodDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with a diagnosis of primary insomnia

You may not qualify if:

  • Patients with an active psychiatric disorder other than primary 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 16, 2005

Study Start

November 1, 2005

Primary Completion

March 1, 2007

Last Updated

January 14, 2015

Record last verified: 2015-01