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Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)

This study has been completed.
Information provided by:
H. Lundbeck A/S Identifier:
First received: January 21, 2005
Last updated: January 13, 2015
Last verified: January 2015
A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia for insomnia (a sleep disorder).

Condition Intervention Phase
Drug: gaboxadol
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, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia

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

Primary Outcome Measures:
  • Amount of time spent awake and time to fall asleep during one night [ Time Frame: one night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of deep sleep during one night. [ Time Frame: one night ] [ Designated as safety issue: No ]
  • Patient-reported sleep quality and awakenings during 1 night. [ Time Frame: one night ] [ Designated as safety issue: No ]

Enrollment: 663
Study Start Date: February 2005
Study Completion Date: December 2005
Intervention Details:
    Drug: gaboxadol
    Duration of Treatment -1 day
    Other Name: MK0928

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adults who are between the ages of 18 and 64

Exclusion Criteria:

  • Adults who are diagnosed with insomnia
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00102167

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: NCT00102167     History of Changes
Other Study ID Numbers: 0928-006  MK0928-006  2004_092 
Study First Received: January 21, 2005
Last Updated: January 13, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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 processed this record on October 26, 2016