Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
NCT00792298 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254
Last updated 2018-11-06
Summary
A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
Conditions
- Primary Insomnia
Interventions
- DRUG
-
Suvorexant
oral tablet taken before bedtime
- DRUG
-
Dose-matched Placebo to Suvorexant
Dose-matched placebo to suvorexant taken before bedtime (oral tablet)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-05
- Primary Completion
- 2009-12-26
- Completion
- 2009-12-26
More Related Trials
-
Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia
NCT04706091 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
NCT06655883 ·Status: RECRUITING ·Phase: PHASE3
-
Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
NCT00420810 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy of Suvorexant on Post-operative Sleep Disturbance
NCT05823844 ·Status: RECRUITING ·Phase: PHASE4
-
Suvorexant and Sleep/Delirium in ICU Patients
NCT04092894 ·Status: COMPLETED ·Phase: PHASE4
-
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
NCT03818581 ·Status: COMPLETED ·Phase: PHASE4
-
MK0928 Study in Adult Patients With Primary Insomnia (0928-040)(COMPLETED)
NCT00266344 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)
NCT00095069 ·Status: COMPLETED ·Phase: PHASE3
-
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)
NCT00266357 ·Status: TERMINATED ·Phase: PHASE2
-
An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)
NCT00102154 ·Status: WITHDRAWN ·Phase: PHASE3
-
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
NCT03642028 ·Status: RECRUITING ·Phase: PHASE4
-
Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)
NCT00094627 ·Status: COMPLETED ·Phase: PHASE3
-
REPOSE Study: Reducing Delirium by Enhancing Postoperative Sleep With Suvorexant
NCT05733286 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of MK0928 on Insomnia in the Elderly (0928-005)(COMPLETED)
NCT00095043 ·Status: COMPLETED ·Phase: PHASE3
-
An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
NCT00103818 ·Status: COMPLETED ·Phase: PHASE3
-
Suvorexant and Trauma Related Insomnia
NCT02704754 ·Status: COMPLETED ·Phase: PHASE4
-
Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
NCT02491788 ·Status: COMPLETED ·Phase: PHASE4
-
Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder
NCT02849548 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1)
NCT01311882 ·Status: COMPLETED ·Phase: PHASE1
-
Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)
NCT00094666 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of LY2624803 in Participants With Transient Insomnia
NCT01779830 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder
NCT06680505 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime In Subjects With Primary Insomnia
NCT00354809 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
NCT03034018 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
NCT02549027 ·Status: COMPLETED ·Phase: PHASE1