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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This study has been withdrawn prior to enrollment.
Information provided by:
H. Lundbeck A/S Identifier:
First received: January 21, 2005
Last updated: January 13, 2015
Last verified: August 2014
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

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
  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: NCT00102154

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

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp Identifier: NCT00102154     History of Changes
Other Study ID Numbers: 0928-007
Study First Received: January 21, 2005
Last Updated: January 13, 2015

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 September 20, 2017