Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy (RESET-HA)

  • STATUS
    Recruiting
  • End date
    Sep 22, 2024
  • participants needed
    160
  • sponsor
    Tremeau Pharmceuticals, Inc.
Updated on 7 October 2022

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.

Details
Condition Hemophilic Arthropathy
Treatment Placebo, TRM-201 (Rofecoxib)
Clinical Study IdentifierNCT04684511
SponsorTremeau Pharmceuticals, Inc.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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