Back to resultsAn Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
gaboxadol
Comparator: placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria: Adult outpatients who are between the ages of 18 and 64 Exclusion Criteria: Adults who do not have a diagnosis of insomnia (a sleep disorder)
Sites / Locations
Outcomes
Primary Outcome Measures
Patient-reported amount of sleep and time to fall asleep at night after 3 months
Secondary Outcome Measures
Patient-reported awakenings at night
Sleep quality
Functioning after 3 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00103818
Brief Title
An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
Official Title
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
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
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of MK0928 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
900 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gaboxadol
Other Intervention Name(s)
MK0928
Intervention Description
Duration of Treatment: 3 months
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified)
Intervention Description
Duration of Treatment: 3 months
Primary Outcome Measure Information:
Title
Patient-reported amount of sleep and time to fall asleep at night after 3 months
Time Frame
After 3 months
Secondary Outcome Measure Information:
Title
Patient-reported awakenings at night
Time Frame
After 3 months
Title
Sleep quality
Time Frame
After 3 months
Title
Functioning after 3 months
Time Frame
After 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult outpatients who are between the ages of 18 and 64
Exclusion Criteria:
Adults who do not have a diagnosis of insomnia (a sleep disorder)
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
20191935
Citation
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.
Results Reference
derived
Learn more about this trial
An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
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