An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia
This study has been terminated.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00102154
First received: January 21, 2005
Last updated: January 21, 2010
Last verified: January 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 21, 2005 | ||||
| Last Updated Date | January 21, 2010 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00102154 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW) | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia | ||||
| Official Title ICMJE | A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia | ||||
| Brief Summary | A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder). |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
||||
| Condition ICMJE | Insomnia | ||||
| Intervention ICMJE | Drug: MK0928, gaboxadol / Duration of Treatment: 10 months | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 45 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00102154 | ||||
| Other Study ID Numbers ICMJE | 2004_093, MK0928-007 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Merck | ||||
| Verification Date | January 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||