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NCT02348606 · ClinicalTrials.gov registry record · Phase 3
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
A Phase 3 study of Obstructive Sleep Apnea, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 476
- Enrollment target
- 20
- Study locations
NCT02348606: Completed Phase 3 study of Obstructive Sleep Apnea, sponsored by Jazz Pharmaceuticals.
NCT02348606 is a Phase 3 study of Obstructive Sleep Apnea that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 476 participants, above the 219-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (117% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02348606, a Phase 3 study of Obstructive Sleep Apnea, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 476 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
Primary Outcome
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.
Conditions Studied
Interventions
- DRUG Placebo oral tablet
- DRUG JZP-110
Study Locations (20)
California
- UC San Diego Medical Center - La Jolla
- So Cal Institute For Respiratory Diseases, Inc. - Los Angeles
- Pacific Sleep Medicine - Oceanside
- Stanford University Center for Narcolepsy - Redwood City
- Pacific Research Network, Inc. - San Diego
Florida
- PAB Clinical Research - Brandon
- MD Clinical - Hallandale
- Clinical Research Group of St. Petersburg - St. Petersburg
- Florida Pediatric Research Institute - Winter Park
Arizona
- Pulmonary Associates - Glendale
- Mayo Clinic in Arizona - Scottsdale
Georgia
- NeuroTrials Research Inc. - Atlanta
- SleepMed of Central Georgia - Macon
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
- University of Illinois at Chicago College of Nursing - Chicago
Maryland
- Johns Hopkins Hospital - Baltimore
- The Center for Sleep & Wake Disorders - Chevy Chase
Arkansas
- Preferred Research Partners - Little Rock
Kentucky
- Kentucky Research Group - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 476 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
What the finished NCT02348606 record still lists
NCT02348606 is an interventional study that assigns participants to a tested intervention. The registered 476 participants enrollment target is mid-sized for trials with a published cap, above the 219-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (117% higher).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT02348606 names 20 study sites across 9 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT02348606 about?
NCT02348606 is a clinical study titled ""Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"". This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
What is the current status of trial NCT02348606?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 476 participants. The study started on 2015-05. Estimated completion is 2016-12.
What conditions does trial NCT02348606 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT02348606?
The interventions under investigation include: Placebo oral tablet (DRUG), JZP-110 (DRUG).
Who is sponsoring clinical trial NCT02348606?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02348606 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02348606's enrollment target sits among peer trials
476 15th of 155 higher than 141 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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