EUCTR2020-003602-31-PL
Active, not recruiting
Phase 1
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study with a Long-Term, Open-label Extension to Evaluate the Efficacy and Safety of TRM-201 (Rofecoxib) in Patients with Hemophilic Arthropathy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hemophilic Arthropathy
- Sponsor
- Tremeau Pharmaceuticals, Inc.
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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,
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:
Outcomes
Primary Outcomes
Not specified
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