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An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102154
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 an investigational drug for insomnia (a sleep disorder).

Condition Intervention Phase
Insomnia Drug: MK0928, gaboxadol / Duration of Treatment: 10 months 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:
  • 4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability

Secondary Outcome Measures:
  • Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)

Enrollment: 0
Study Start Date: January 2005
  Eligibility

Information from the National Library of Medicine

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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): NCT00102154


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

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00102154     History of Changes
Other Study ID Numbers: 0928-007
2004_093
First Submitted: January 21, 2005
First Posted: January 24, 2005
Last Update Posted: January 14, 2015
Last Verified: August 2014

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