Text Size

Elderly Primary Insomnia Polysomnographic Study

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00094666
First received: October 21, 2004
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Merck:

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)
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elderly patients with a diagnosis of primary insomnia and in good physical and mental health
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00094666

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

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00094666     History of Changes
Other Study ID Numbers: 2004_085, MK0928-002
Study First Received: October 21, 2004
Last Updated: January 21, 2010
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 22, 2013