Back to resultsAn Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)
Primary Purpose
Insomnia
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0928, gaboxadol / Duration of Treatment: 10 months
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria: Healthy adults who are between the ages of 18 and 64 Exclusion Criteria: Adults who are diagnosed with insomnia
Sites / Locations
Outcomes
Primary Outcome Measures
4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability
Secondary Outcome Measures
Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00102154
Brief Title
An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
5. Study Description
Brief Summary
A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0928, gaboxadol / Duration of Treatment: 10 months
Primary Outcome Measure Information:
Title
4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability
Secondary Outcome Measure Information:
Title
Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults who are between the ages of 18 and 64
Exclusion Criteria:
Adults who are diagnosed with insomnia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)
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