Back to resultsStudy of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
gaboxadol
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
Amount of time spent awake and time to fall asleep during one night
Secondary Outcome Measures
Amount of deep sleep during one night.
Patient-reported sleep quality and awakenings during 1 night.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00102167
Brief Title
Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)
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
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
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 Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia 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
663 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gaboxadol
Other Intervention Name(s)
MK0928
Intervention Description
Duration of Treatment -1 day
Primary Outcome Measure Information:
Title
Amount of time spent awake and time to fall asleep during one night
Time Frame
one night
Secondary Outcome Measure Information:
Title
Amount of deep sleep during one night.
Time Frame
one night
Title
Patient-reported sleep quality and awakenings during 1 night.
Time Frame
one night
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
Citations:
PubMed Identifier
17765013
Citation
Walsh JK, Mayleben D, Guico-Pabia C, Vandormael K, Martinez R, Deacon S. Efficacy of the selective extrasynaptic GABA A agonist, gaboxadol, in a model of transient insomnia: a randomized, controlled clinical trial. Sleep Med. 2008 May;9(4):393-402. doi: 10.1016/j.sleep.2007.06.006. Epub 2007 Aug 30.
Results Reference
background
PubMed Identifier
22003345
Citation
Ma J, Dijk DJ, Svetnik V, Tymofyeyev Y, Ray S, Walsh JK, Deacon S. EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women. J Clin Sleep Med. 2011 Oct 15;7(5):493-501A. doi: 10.5664/JCSM.1316.
Results Reference
derived
Learn more about this trial
Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)
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