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An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00102154
Recruitment Status : Withdrawn
First Posted : January 24, 2005
Last Update Posted : January 14, 2015
Information provided by:

January 21, 2005
January 24, 2005
January 14, 2015
January 2005
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4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability
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Complete list of historical versions of study NCT00102154 on ClinicalTrials.gov Archive Site
Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)
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An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia
A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Drug: MK0928, gaboxadol / Duration of Treatment: 10 months
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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Inclusion Criteria:

  • Healthy adults who are between the ages of 18 and 64

Exclusion Criteria:

  • Adults who are diagnosed with insomnia
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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Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
H. Lundbeck A/S
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
H. Lundbeck A/S
August 2014

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