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Cox-2 Inhibitor

TRM-201 (Rofecoxib) for Hemophilic Arthropathy (RESET-HA Trial)

Phase 3
Waitlist Available
Research Sponsored by Tremeau Pharmceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

RESET-HA Trial Summary

This trial is testing a new drug, TRM-201, to see if it is better than placebo at treating hemophilic arthropathy (HA) over 12 weeks and if it is safe to use for a year.

Eligible Conditions
  • Hemophilic Arthropathy

RESET-HA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change from baseline in the patient assessment of the daily Average Hemophilic arthropathy Pain Intensity score on a 0- to 10-point numeric rating scale where 0 = no pain and 10 = pain as bad as you can imagine.

RESET-HA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TRM-201 (Rofecoxib)Experimental Treatment1 Intervention
1 TRM-201 tablet taken orally once daily for 12 weeks in Part I and orally once daily for an additional 52 weeks in Part II
Group II: PlaceboPlacebo Group1 Intervention
1 placebo tablet (to match TRM-201) taken orally once daily for 12 weeks in Part I and then 1 TRM-201 tablet taken orally once daily for an additional 52 weeks in Part II

Find a Location

Who is running the clinical trial?

Tremeau Pharmceuticals, Inc.Lead Sponsor
Judith Boice, PhDStudy DirectorTremeau Pharmaceuticals

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
University of Florida - Shands
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Florida - Shands: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy
2021. "Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684511.
~1 spots leftby Apr 2025
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