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Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy

NCT04684511 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-10-27

No results posted yet for this study

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

DRUG

TRM-201 (Rofecoxib)

Eligible patients will be randomized to receive TRM-201 or placebo

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

  • Tremeau Pharmceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Judith Boice, PhD · Tremeau Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2022-09-28
Completion
2022-09-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Italy
  • Poland
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04684511 on ClinicalTrials.gov