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

Hemophilic Arthropathy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04684511
Study type	Interventional
Source	Tremeau Pharmceuticals, Inc.
Contact
Status	Terminated
Phase	Phase 3
Start date	June 2, 2021
Completion date	September 28, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01232634` - Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles	Phase 2
Completed	`NCT02994147` - A Proof-of-Concept Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Hemophilic Arthropathy	Phase 2
Completed	`NCT02601170` - Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy	N/A
Recruiting	`NCT05517070` - Vitamin D Deficiency and Body Composition in the Patients With Hemophilia
Completed	`NCT04297696` - The Effects of Exercises on Gait in Hemophilic Individuals	N/A
Completed	`NCT04535180` - Sarcopenia and Osteoporosis in the Patients With Hemophilia
Terminated	`NCT02569359` - Efficacy and Safety of Shea Nut Oil in Hemophilic Arthropathy	N/A