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Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)

This study has been terminated.
Information provided by:
H. Lundbeck A/S Identifier:
First received: October 21, 2004
Last updated: January 13, 2015
Last verified: January 2015
The purpose of the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly.

Condition Intervention Phase
Primary Insomnia
Drug: MK0928, gaboxadol / Duration of Treatment - 6 weeks
Drug: Comparator: placebo / Duration of Treatment - 6 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Elderly Patients With Primary Insomnia

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

Primary Outcome Measures:
  • Amount of time spent awake and time to fall asleep at night after two days

Secondary Outcome Measures:
  • Amount of time spent awake and time to fall asleep at night after 30 days
  • Amount of deep sleep after two days

Estimated Enrollment: 465
Study Start Date: November 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elderly patients with a diagnosis of primary insomnia and in good physical and mental health
  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: NCT00094666

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: NCT00094666     History of Changes
Other Study ID Numbers: 0928-002  MK0928-002  2004_085 
Study First Received: October 21, 2004
Last Updated: January 13, 2015
Health Authority: United States: Food and Drug Administration

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 December 02, 2016