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
The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).

Condition Intervention Phase
Drug: gaboxadol
Drug: Comparator: placebo (unspecified)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 900
Study Start Date: February 2005
Study Completion Date: October 2006
Intervention Details:
    Drug: gaboxadol
    Duration of Treatment: 3 months
    Other Name: MK0928
    Drug: Comparator: placebo (unspecified)
    Duration of Treatment: 3 months

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00103818

Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp Identifier: NCT00103818     History of Changes
Other Study ID Numbers: 0928-014  MK0928-014  2005_002 
Study First Received: February 15, 2005
Last Updated: January 13, 2015
Health Authority: United States: Food and Drug Administration processed this record on May 26, 2016