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An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(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: NCT00103818
Recruitment Status : Completed
First Posted : February 16, 2005
Last Update Posted : January 14, 2015
Information provided by:
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Insomnia Drug: gaboxadol Drug: Comparator: placebo (unspecified) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2005
Actual 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

Primary Outcome Measures :
  1. Patient-reported amount of sleep and time to fall asleep at night after 3 months [ Time Frame: After 3 months ]

Secondary Outcome Measures :
  1. Patient-reported awakenings at night [ Time Frame: After 3 months ]
  2. Sleep quality [ Time Frame: After 3 months ]
  3. Functioning after 3 months [ Time Frame: After 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103818

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp Identifier: NCT00103818    
Other Study ID Numbers: 0928-014
First Posted: February 16, 2005    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action