Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00266357
First received: December 14, 2005
Last updated: January 13, 2015
Last verified: January 2015

December 14, 2005
January 13, 2015
November 2005
March 2007   (final data collection date for primary outcome measure)
Mean of total sleep time over 2 nights.
Same as current
Complete list of historical versions of study NCT00266357 on ClinicalTrials.gov Archive Site
Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.
Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory redidual effect.
Not Provided
Not Provided
 
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)
MK0928 Phase II Sleep Laboratory Study - Primary Insomnia

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Primary Insomnia
  • Drug: MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)
  • Drug: Placebo / Duration of Treatment: 2 days for screening period
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
Not Provided
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a diagnosis of primary insomnia

Exclusion Criteria:

  • Patients with an active psychiatric disorder other than primary insomnia
Both
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT00266357
0928-041, 2005_107
Not Provided
Not Provided
H. Lundbeck A/S
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
H. Lundbeck A/S
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP