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An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)

This study has been completed.
Information provided by:
H. Lundbeck A/S Identifier:
First received: February 15, 2005
Last updated: January 13, 2015
Last verified: January 2015
The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).

Condition Intervention Phase
Insomnia Drug: gaboxadol Drug: Comparator: placebo (unspecified) 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, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Patient-reported amount of sleep and time to fall asleep at night after 3 months [ Time Frame: After 3 months ]

Secondary Outcome Measures:
  • Patient-reported awakenings at night [ Time Frame: After 3 months ]
  • Sleep quality [ Time Frame: After 3 months ]
  • Functioning after 3 months [ Time Frame: After 3 months ]

Enrollment: 900
Study Start Date: February 2005
Study Completion Date: October 2006
Intervention Details:
    Drug: gaboxadol
    Duration of Treatment: 3 months
    Other Name: MK0928
    Drug: Comparator: placebo (unspecified)
    Duration of Treatment: 3 months

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult outpatients who are between the ages of 18 and 64

Exclusion Criteria:

  • Adults who do not have a diagnosis of insomnia (a sleep disorder)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00103818

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp Identifier: NCT00103818     History of Changes
Other Study ID Numbers: 0928-014
Study First Received: February 15, 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 21, 2017