Efficacy and Safety of MK0928 for Insomnia in Adults

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00095069
First received: October 29, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.


Condition Intervention Phase
Insomnia
Drug: MK0928, gaboxadol / Duration of Treatment - 1 year
Drug: Comparator: placebo / Duration of Treatment -1 year
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-Groups Efficacy and Safety Extension Study of MK0928 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 sleep at night after three months

Secondary Outcome Measures:
  • Patient-reported awakenings at night
  • Sleep quality
  • Functioning after 3 months

Estimated Enrollment: 600
Study Start Date: October 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of insomnia
  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: NCT00095069

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: NCT00095069     History of Changes
Other Study ID Numbers: 2004_086, MK0928-003
Study First Received: October 29, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014