drugset / Trial / NCT04684511

Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy

NCT04684511

Phase 3 Terminated 2 enrolled Tremeau Pharmceuticals, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2021-06-02
Primary completion
2022-09-28
Completion
2022-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject rofecoxib Small molecule Oral