MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)

This study has been completed.
Information provided by:
H. Lundbeck A/S Identifier:
First received: December 14, 2005
Last updated: January 13, 2015
Last verified: January 2015

A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.

Condition Intervention Phase
Primary Insomnia
Drug: MK0928, gaboxadol / Duration of Treatment 3 Weeks
Drug: Placebo / Duration of Treatment 3 Weeks
Phase 2

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: MK0928 Phase IIb Dose-range Finding Study -Primary Insomnia

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

Primary Outcome Measures:
  • Patient-reported total sleep time.

Secondary Outcome Measures:
  • Patient-reported time to sleep onset, number of awakenings, wake time after sleep onset and premature awakening.

Estimated Enrollment: 520
Study Start Date: November 2005
Study Completion Date: October 2006

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a diagnosis of primary insomnia

Exclusion Criteria:

  • Patients with an active psychiatric disorder other than primary 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 identifier: NCT00266344

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. Identifier: NCT00266344     History of Changes
Other Study ID Numbers: 0928-040, MK0928-040, 2005_106
Study First Received: December 14, 2005
Last Updated: January 13, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic processed this record on October 07, 2015