Hemophilic Arthropathy
Conditions
Interventions
Product Name: Rofecoxib
Product Code: [TRM-201]
Pharmaceutical Form: Tablet
CAS Number: 162011-90-7
Current Sponsor code: RM-201
Concentration unit: µg microgram(s)
Concentration type: equal
Concentra
Sponsors
Tremeau Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 5 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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 |
|---|---|
| Main Objective: To evaluate the efficacy of TRM-201 (rofecoxib) 17.5 mg versus placebo in patients with hemophilic arthropathy as measured by patient assessment of hemophilic arthropathy average pain intensity.;Secondary Objective: 1. To evaluate the efficacy of TRM-201 (rofecoxib) 17.5 mg versus placebo on physical function in patients with hemophilic arthropathy as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function-Short Form 10a. 2. To evaluate the efficacy of TRM-201 (rofecoxib) 17.5 mg versus placebo in patients with hemophilic arthropathy as measured by patient assessment of hemophilic arthropathy worst pain intensity. 3. To evaluate the efficacy of TRM-201 (rofecoxib) 17.5 mg versus placebo in patients with hemophilic arthropathy as measured by the Pain Interference Domain from the Brief Pain Inventory (BPI). 4. To evaluate the efficacy of TRM-201 (rofecoxib) 17.5 mg versus placebo in patients with hemophilic arthropathy as measured by patient assessment of average hemophilic arthropathy pain intensity in the selected most painful joint.;Primary end point(s): The change from baseline in the patient assessment of the daily hemophilic arthropathy pain score (average pain over the past 24 hours on a 0- to 10-point numeric rating scale) at Week 12 (assessed daily).;Timepoint(s) of evaluation of this end point: As per the Protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The change from baseline in the PROMIS Physical Function-Short Form 10a score at Week 12 (assessed once weekly). 2. The change from baseline in the patient assessment of the daily hemophilic arthropathy pain score (worst pain over the past 24 hours on a 0- to 10-point numeric rating scale) at Week 12 (assessed daily). 3. The change from baseline in the Pain Interference score from the BPI at Week 12 (assessed once weekly). 4. The change from baseline in the patient assessment of hemophilic arthropathy pain intensity in the selected most painful joint (average pain over the past 24 hours) at Week 12 (assessed once weekly). Note: The same joint is to be followed throughout Part I. Other Secondary Endpoints 1. The change from baseline in the PROMIS Sleep Disturbance-Short Form 4a score at Week 12 (assessed at clinic visits). 2. The change from baseline in the PGI-S – Joint Symptoms (assessed at baseline and end of Part I). 3. The change from baseline in the EQ-5D-5L Health Status score at Week 12 (assessed at clinic visits).;Timepoint(s) of evaluation of this end point: As per the Protocol | — |
Countries
Australia, Brazil, Canada, Italy, Poland, Russian Federation, Spain, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Operations
Tremeau Pharmaceuticals, Inc.
Outcome results
None listed