An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia
3 other identifiers
interventional
900
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2005
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
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 15, 2005
CompletedFirst Posted
Study publicly available on registry
February 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedJanuary 14, 2015
January 1, 2015
February 15, 2005
January 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Patient-reported amount of sleep and time to fall asleep at night after 3 months
After 3 months
Secondary Outcomes (3)
Patient-reported awakenings at night
After 3 months
Sleep quality
After 3 months
Functioning after 3 months
After 3 months
Interventions
Duration of Treatment: 3 months
Eligibility Criteria
You may qualify if:
- Adult outpatients who are between the ages of 18 and 64
You may not qualify if:
- Adults who do not have a diagnosis of insomnia (a sleep disorder)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
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
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
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
February 15, 2005
First Posted
February 16, 2005
Study Start
February 1, 2005
Study Completion
October 1, 2006
Last Updated
January 14, 2015
Record last verified: 2015-01