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Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00420810
Recruitment Status : Terminated
First Posted : January 11, 2007
Last Update Posted : January 14, 2015
Information provided by:
H. Lundbeck A/S

January 5, 2007
January 11, 2007
January 14, 2015
September 2006
March 2007   (Final data collection date for primary outcome measure)
Wake after sleep onset and Latency to persistent sleep
Same as current
Complete list of historical versions of study NCT00420810 on ClinicalTrials.gov Archive Site
Subjective total sleep time and subjective time to sleep onset
Same as current
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Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia
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.
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Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Primary Insomnia
Drug: MK0928 / Duration of Treatment : 8 Weeks
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
March 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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United States
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H. Lundbeck A/S
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
H. Lundbeck A/S
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP