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Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 1, 2004
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
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
Not Provided
Complete list of historical versions of study NCT00095069 on ClinicalTrials.gov Archive Site
  • Patient-reported awakenings at night
  • Sleep quality
  • Functioning after 3 months
Not Provided
Not Provided
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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.
Not Provided
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
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
Not Provided
United States
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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
January 2015

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