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Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy

Phase 3
Terminated
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
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
PlaceboPlacebo1 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
NameTimeMethod
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
NameTimeMethod

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

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