NCT00095043

Brief Summary

The purpose of this trial is to study the safety of MK0928 on insomnia in the elderly.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

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
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

October 29, 2004

Last Update Submit

November 16, 2016

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability after 12 months of treatment

Secondary Outcomes (1)

  • Discontinuation symptoms and rebound insomnia using sleep diary and Tyrer Withdrawal Symptom Questionnaire

Interventions

MK0928, gaboxadolDRUG
Comparator: placeboDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosis of Insomnia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

gaboxadol

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2004

First Posted

November 1, 2004

Study Start

October 1, 2004

Primary Completion

June 1, 2006

Last Updated

November 17, 2016

Record last verified: 2016-11