Status:
TERMINATED
Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy
Lead Sponsor:
Tremeau Pharmceuticals, Inc.
Conditions:
Hemophilic Arthropathy
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04684511
Start Date
June 2 2021
End Date
September 28 2022
Last Update
October 27 2022
Active Locations (46)
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1
Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center
Los Angeles, California, United States, 90007
2
Center for Inherited Blood Disorders
Orange, California, United States, 92868
3
UC Davis Children's Hospital
Sacramento, California, United States, 95817
4
University of Colorado Hemophilia & Thrombosis Center
Aurora, Colorado, United States, 80045