Back to resultsAdult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
Primary Purpose
Primary Insomnia
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0928 / Duration of Treatment : 8 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Primary Insomnia
- Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
- Patient is willing to avoid alcohol on PSG visits
- Patient will avoid napping during the course of the study
- Patient's bedtime is between 9pm and 1am
Exclusion Criteria:
- History of substance abuse, bipolar disorder or psychotic disorder
- Difficulty sleeping due to other medical condition
- History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
- History of neoplastic malignancy within the last 5 years
- Positive alcohol breath test during the screening visits
Sites / Locations
Outcomes
Primary Outcome Measures
Wake after sleep onset and Latency to persistent sleep
Secondary Outcome Measures
Subjective total sleep time and subjective time to sleep onset
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00420810
Brief Title
Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
Official Title
A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Study Start Date
September 2006 (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
The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.
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 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
138 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0928 / Duration of Treatment : 8 Weeks
Primary Outcome Measure Information:
Title
Wake after sleep onset and Latency to persistent sleep
Secondary Outcome Measure Information:
Title
Subjective total sleep time and subjective time to sleep onset
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:
Diagnosis of Primary Insomnia
Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
Patient is willing to avoid alcohol on PSG visits
Patient will avoid napping during the course of the study
Patient's bedtime is between 9pm and 1am
Exclusion Criteria:
History of substance abuse, bipolar disorder or psychotic disorder
Difficulty sleeping due to other medical condition
History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
History of neoplastic malignancy within the last 5 years
Positive alcohol breath test during the screening visits
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
Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
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