Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(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: NCT00095069
Recruitment Status : Completed
First Posted : November 1, 2004
Last Update Posted : January 14, 2015
Information provided by:
H. Lundbeck A/S

October 29, 2004
November 1, 2004
January 14, 2015
October 2004
February 2007   (Final data collection date for primary outcome measure)
Patient-reported amount of sleep and time to fall sleep at night after three months
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Complete list of historical versions of study NCT00095069 on Archive Site
  • Patient-reported awakenings at night
  • Sleep quality
  • Functioning after 3 months
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Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)
A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Groups Efficacy and Safety Extension Study of MK0928 in the Treatment of Adult Outpatients With Primary Insomnia
The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.
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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 - 1 year
  • Drug: Comparator: placebo / Duration of Treatment -1 year
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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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February 2007
February 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of 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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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