We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00103818
First Posted: February 16, 2005
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
H. Lundbeck A/S
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103818


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00103818     History of Changes
Other Study ID Numbers: 0928-014
MK0928-014
2005_002
First Submitted: February 15, 2005
First Posted: February 16, 2005
Last Update Posted: January 14, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Gaboxadol
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action