This is a multicenter, randomized, double-blind study to evaluate the efficacy and safety of TRM-201 (rofecoxib) versus Placebo in the treatment of patients with hemophilic arthropathy (HA) over a 12-week period (Part I) that is followed by a year-long (52 week) open-label extension (Part II) to further evaluate the safety and maintenance of efficacy of TRM-201.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2
Eligible patients will be randomized to receive TRM-201 or placebo
Matching Placebo
The change from baseline in the patient assessment of the daily Average Hemophilic arthropathy Pain Intensity score on a 0- to 10-point numeric rating scale where 0 = no pain and 10 = pain as bad as you can imagine.
Time frame: 12 weeks
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Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center
Los Angeles, California, United States
Center for Inherited Blood Disorders
Orange, California, United States
UC Davis Children's Hospital
Sacramento, California, United States
University of Colorado Hemophilia & Thrombosis Center
Aurora, Colorado, United States
Georgetown University Hospital - Medstar
Washington D.C., District of Columbia, United States
University of Florida - Shands
Gainesville, Florida, United States
Clinical Trial Services, Corp
Miami, Florida, United States
Anchor Medical Research, LLC
Miami, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
...and 36 more locations