Hemophilic Arthropathy
Conditions
Keywords
Hemophilia, Pain, HA, Joint Pain
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.
Interventions
DRUGTRM-201 (Rofecoxib)
Eligible patients will be randomized to receive TRM-201 or placebo
DRUGPlacebo
Matching Placebo
Sponsors
Tremeau Pharmceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia, Canada, Italy, Poland, Spain, Turkey (Türkiye), Ukraine, United States
Outcome results
None listed