NCT04684511

Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Tremeau Pharmceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilic Arthropathy

Interventions

Type	Name	Description
DRUG	TRM-201 (Rofecoxib)	Eligible patients will be randomized to receive TRM-201 or placebo
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2021-06-02
• Primary completion: 2022-09-28
• Completion: 2022-09-28
• First posted: 2020-12-24
• Last updated: 2022-10-27

Locations

46 sites across 8 countries: United States, Australia, Canada, Italy, Poland, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study