Working… Menu

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

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: NCT00102154
Recruitment Status : Withdrawn
First Posted : January 24, 2005
Last Update Posted : January 14, 2015
Information provided by:
H. Lundbeck A/S

Brief Summary:
A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).

Condition or disease Intervention/treatment Phase
Insomnia Drug: MK0928, gaboxadol / Duration of Treatment: 10 months Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : January 2005

Primary Outcome Measures :
  1. 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 :
  1. Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW)

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00102154

Sponsors and Collaborators
H. Lundbeck A/S
Layout table for investigator information
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Layout table for additonal information
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp Identifier: NCT00102154    
Other Study ID Numbers: 0928-007
First Posted: January 24, 2005    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: August 2014
Additional relevant MeSH terms:
Layout table for 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