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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NCT00420810 |
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Date of registration:
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05/01/2007 |
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Primary sponsor: |
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Public title:
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Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
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Scientific title:
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A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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138 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00420810 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Insomnia
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Intervention(s)
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Drug: MK0928 / Duration of Treatment : 8 Weeks
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Primary Outcome(s)
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Wake after sleep onset and Latency to persistent sleep
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Secondary Outcome(s)
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Subjective total sleep time and subjective time to sleep onset
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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