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An Investigational Study of MK0928 in Adult Outpatients With Insomnia

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00103818
First received: February 15, 2005
Last updated: January 25, 2010
Last verified: January 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Patient-reported amount of sleep and time to fall asleep at night after 3 months [ Time Frame: After 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-reported awakenings at night [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: After 3 months ] [ Designated as safety issue: No ]
  • Functioning after 3 months [ Time Frame: After 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
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: NCT00103818

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional 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: 2005_002, MK0928-014
Study First Received: February 15, 2005
Last Updated: January 25, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014