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Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00420810
First received: January 5, 2007
Last updated: January 13, 2015
Last verified: January 2015
  Purpose
The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.

Condition Intervention Phase
Primary Insomnia Drug: MK0928 / Duration of Treatment : 8 Weeks Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia

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

Primary Outcome Measures:
  • Wake after sleep onset and Latency to persistent sleep

Secondary Outcome Measures:
  • Subjective total sleep time and subjective time to sleep onset

Estimated Enrollment: 138
Study Start Date: September 2006
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Diagnosis of Primary Insomnia
  • Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
  • Patient is willing to avoid alcohol on PSG visits
  • Patient will avoid napping during the course of the study
  • Patient's bedtime is between 9pm and 1am

Exclusion Criteria:

  • History of substance abuse, bipolar disorder or psychotic disorder
  • Difficulty sleeping due to other medical condition
  • History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
  • History of neoplastic malignancy within the last 5 years
  • Positive alcohol breath test during the screening visits
  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 ClinicalTrials.gov identifier: NCT00420810

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

ClinicalTrials.gov Identifier: NCT00420810     History of Changes
Other Study ID Numbers: 0928-049
2006_514
Study First Received: January 5, 2007
Last Updated: January 13, 2015

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 25, 2017