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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102167
First Posted: January 24, 2005
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
  Purpose
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
Insomnia Drug: gaboxadol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Amount of deep sleep during one night. [ Time Frame: one night ]
  • Patient-reported sleep quality and awakenings during 1 night. [ Time Frame: one night ]

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

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.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Adults who are diagnosed with insomnia
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00102167


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00102167     History of Changes
Other Study ID Numbers: 0928-006
MK0928-006
2004_092
First Submitted: January 21, 2005
First Posted: January 24, 2005
Last Update Posted: January 14, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Gaboxadol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action