Efficacy and Safety of MK0928 for Insomnia in Adults

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00095069
First received: October 29, 2004
Last updated: January 21, 2010
Last verified: January 2010

October 29, 2004
January 21, 2010
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
Not Provided
 
Efficacy and Safety of MK0928 for Insomnia in Adults
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Insomnia
  • 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.
 
Completed
600
February 2007
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of insomnia
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00095069
2004_086, MK0928-003
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2010

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