Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy
- Conditions
- Hemophilic Arthropathy
- Interventions
- Drug: TRM-201 (Rofecoxib)Drug: Placebo
- Registration Number
- NCT04684511
- Lead Sponsor
- Tremeau Pharmceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- Diagnosis of hemophilia A or B
- Either on a stable prophylaxis regimen for their bleeding disorder (factor, bypassing agent, or nonfactor product therapy) OR currently taking or agree to initiate a gastroprotective agent (esomeprazole) for the duration of the trial
- Diagnosis of Hemophilic Arthopathy for at least 6 months prior to screening
- Chronic symptomatic pain in one or more joint(s) on 20 of the 30 days prior to screening.
- Able and willing to wash out of non-study analgesic medications/agents for at least 7 days prior to Randomization including: acetaminophen (paracetamol), NSAIDs, opioids, cannabinoids, topical analgesics, benzodiazepines, gabapentin/pregabalin-containing products and other antiepileptic drugs used for pain
- Primary source of pain is due to Hemophilic Arthropathy
- Taking opioids for greater than 4 days per week prior to screening
- Has a history of advanced renal disease or severe liver disease (within the last 6 months)
- Receiving emicizumab while also receiving activated prothrombin complex concentrate (FEIBA)
- Uncontrolled or poorly controlled hypertension
- History of major cardiac or cerebrovascular disease
- History of an upper GI perforation, obstruction, or major GI bleed or current evidence of GI bleeding
- Has active hepatitis C or hepatitis B infection or uncontrolled HIV. Note: Patients who are HIV positive are allowed to participate if considered to be controlled.
- Has a positive drug screen for all prohibited drugs of potential abuse at screening
- Has had an intra-articular injection (within 3 months), initiated physical therapy (within 30 days) or has had orthopedic surgery (within 4 months) prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TRM-201 (Rofecoxib) TRM-201 (Rofecoxib) 1 TRM-201 tablet taken orally once daily for 12 weeks in Part I and orally once daily for an additional 52 weeks in Part II Placebo Placebo 1 placebo tablet (to match TRM-201) taken orally once daily for 12 weeks in Part I and then 1 TRM-201 tablet taken orally once daily for an additional 52 weeks in Part II
- Primary Outcome Measures
Name Time Method 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. 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
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, 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
Scroll for more (35 remaining)Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center🇺🇸Los Angeles, California, United States