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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102154
First Posted: January 24, 2005
Last Update Posted: January 14, 2015
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.
Information provided by:
H. Lundbeck A/S
January 21, 2005
January 24, 2005
January 14, 2015
January 2005
Not Provided
4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability
Not Provided
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)
Not Provided
Not Provided
Not Provided
 
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Insomnia
Drug: MK0928, gaboxadol / Duration of Treatment: 10 months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00102154
0928-007
2004_093
Not Provided
Not Provided
Not Provided
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