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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00102154
First received: January 21, 2005
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  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
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 Merck:

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102154

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00102154     History of Changes
Other Study ID Numbers: 2004_093, MK0928-007
Study First Received: January 21, 2005
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013