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

This study has been completed.
Information provided by:
H. Lundbeck A/S Identifier:
First received: February 15, 2005
Last updated: January 13, 2015
Last verified: January 2015

February 15, 2005
January 13, 2015
February 2005
Not Provided
Patient-reported amount of sleep and time to fall asleep at night after 3 months [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00103818 on Archive Site
  • Patient-reported awakenings at night [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
  • Functioning after 3 months [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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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).
Not Provided
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Drug: gaboxadol
    Duration of Treatment: 3 months
    Other Name: MK0928
  • Drug: Comparator: placebo (unspecified)
    Duration of Treatment: 3 months
Not Provided
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.
October 2006
Not Provided

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)
18 Years to 64 Years
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
0928-014, MK0928-014, 2005_002
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
January 2015

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