Back to resultsSleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)
Primary Purpose
Primary Insomnia
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)
Placebo / Duration of Treatment: 2 days for screening period
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of primary insomnia Exclusion Criteria: Patients with an active psychiatric disorder other than primary insomnia
Sites / Locations
Outcomes
Primary Outcome Measures
Mean of total sleep time over 2 nights.
Secondary Outcome Measures
Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00266357
Brief Title
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)
Official Title
MK0928 Phase II Sleep Laboratory Study - Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
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 efficacy, safety and tolerability of MK-0928 in Primary Insomnia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)
Intervention Type
Drug
Intervention Name(s)
Placebo / Duration of Treatment: 2 days for screening period
Primary Outcome Measure Information:
Title
Mean of total sleep time over 2 nights.
Secondary Outcome Measure Information:
Title
Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of primary insomnia
Exclusion Criteria:
Patients with an active psychiatric disorder other than primary 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
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)
We'll reach out to this number within 24 hrs