Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
This study has been terminated.
Information provided by:
Merck Sharp & Dohme Corp.
First received: January 5, 2007
Last updated: May 20, 2013
Last verified: May 2013
The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.
Drug: MK0928 / Duration of Treatment : 8 Weeks
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
||A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia
Primary Outcome Measures:
- Wake after sleep onset and Latency to persistent sleep
Secondary Outcome Measures:
- Subjective total sleep time and subjective time to sleep onset
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||March 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 64 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Diagnosis of Primary Insomnia
- Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
- Patient is willing to avoid alcohol on PSG visits
- Patient will avoid napping during the course of the study
- Patient's bedtime is between 9pm and 1am
- History of substance abuse, bipolar disorder or psychotic disorder
- Difficulty sleeping due to other medical condition
- History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
- History of neoplastic malignancy within the last 5 years
- Positive alcohol breath test during the screening visits
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: NCT00420810
Merck Sharp & Dohme Corp.
||Merck Sharp & Dohme Corp.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 5, 2007
||May 20, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2014
Sleep Initiation and Maintenance Disorders
Nervous System Diseases
Sleep Disorders, Intrinsic