An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)

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. Identifier: NCT00103818
Recruitment Status : Completed
First Posted : February 16, 2005
Last Update Posted : January 14, 2015
Information provided by:
H. Lundbeck A/S

February 15, 2005
February 16, 2005
January 14, 2015
February 2005
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Patient-reported amount of sleep and time to fall asleep at night after 3 months [ Time Frame: After 3 months ]
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Complete list of historical versions of study NCT00103818 on Archive Site
  • Patient-reported awakenings at night [ Time Frame: After 3 months ]
  • Sleep quality [ Time Frame: After 3 months ]
  • Functioning after 3 months [ Time Frame: After 3 months ]
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An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia
The purpose of this study is to evaluate the safety and effectiveness of MK0928 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: gaboxadol
    Duration of Treatment: 3 months
    Other Name: MK0928
  • Drug: Comparator: placebo (unspecified)
    Duration of Treatment: 3 months
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Roth T, Lines C, Vandormael K, Ceesay P, Anderson D, Snavely D. Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. J Clin Sleep Med. 2010 Feb 15;6(1):30-9.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2006
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Inclusion Criteria:

  • Adult outpatients who are between the ages of 18 and 64

Exclusion Criteria:

  • Adults who do not have a diagnosis of insomnia (a sleep disorder)
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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Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
H. Lundbeck A/S
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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