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

October 25, 2022 updated by: Tremeau Pharmceuticals, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3004
        • The Alfred Hospital
    • New South Wales
      • Waratah, New South Wales, Australia
        • Calvary Mater Newcastle
    • Western Australia
      • Murdoch, Western Australia, Australia
        • Fiona Stanley Hospital
  • Canada
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, NL A1B3V6
        • Health Sciences Center
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences Centre
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
      • Roma, Italy
        • Ospedale Pediatrico Bambino Gesù
  • Poland
      • Poznań, Poland
        • Centrum Medyczne Pratia Poznań
      • Wrocław, Poland
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Spain
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
  • Turkey
      • Adana, Turkey
        • Acibadem Adana Hospital
      • Antalya, Turkey
        • Akdeniz University Medical Faculty
      • Edirne, Turkey
        • Erciyes University Medical Faculty
      • Gaziantep, Turkey, 27310
        • Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
      • Istanbul, Turkey
        • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
      • Samsun, Turkey
        • Ondokuz Mayis Univ. Med. Fac.
      • İzmir, Turkey, 35100
        • Ege University Medical Faculty
      • İzmir, Turkey
        • Ege University Medical Faculty
  • Ukraine
      • Dnipro, Ukraine
        • CI Dnipropetrovsk CMCH #4 OF Dnipropetrovsk RC
      • Kharkiv, Ukraine
        • CI of Healthcare Kharkiv City Clin Children's Hosp #16 Kharkiv NMU
      • Kyiv, Ukraine
        • Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
      • Kyiv, Ukraine
        • Kyiv CCH #9 City SPC of Diagnostics & Treatment of Patients with HP
      • Kyiv, Ukraine
        • Nat.Children Specialized Hosp.OKHMATDYT of the Ministry of Health of Ukraine
      • Lviv, Ukraine
        • SI Institute of Blood Pathology and Transfusion Medicine of NAMSU
      • Poltava, Ukraine
        • M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy
      • Ternopil', Ukraine
        • CI of TRC Ternopil UH
      • Zaporizhzhya, Ukraine
        • CI Zaporizhzhya Regional Clinical Hospital of ZRC
  • United States
    • California
      • Los Angeles, California, United States, 90007
        • Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center
      • Orange, California, United States, 92868
        • Center for Inherited Blood Disorders
      • Sacramento, California, United States, 95817
        • UC Davis Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hemophilia & Thrombosis Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital - Medstar
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida - Shands
      • Miami, Florida, United States, 33176
        • Anchor Medical Research, Llc
      • Miami, Florida, United States, 33144
        • Clinical Trial Services, Corp
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana Center for Bleeding and Clotting Disorders
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • New York
      • Buffalo, New York, United States, 14202
        • ECMC Hospital
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai.
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • East Carolina University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Texas
      • Dallas, Texas, United States, 75390
        • North Texas Comprehensive Hemophilia Center
      • Houston, Texas, United States, 77030
        • Gulf States Hemophilia and Thrombophilia Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of hemophilia A or B
  • Either on a stable prophylaxis regimen for their bleeding disorder (factor, bypassing agent, or nonfactor product therapy) OR currently taking or agree to initiate a gastroprotective agent (esomeprazole) for the duration of the trial
  • Diagnosis of Hemophilic Arthopathy for at least 6 months prior to screening
  • Chronic symptomatic pain in one or more joint(s) on 20 of the 30 days prior to screening.
  • Able and willing to wash out of non-study analgesic medications/agents for at least 7 days prior to Randomization including: acetaminophen (paracetamol), NSAIDs, opioids, cannabinoids, topical analgesics, benzodiazepines, gabapentin/pregabalin-containing products and other antiepileptic drugs used for pain
  • Primary source of pain is due to Hemophilic Arthropathy

Exclusion Criteria:

  • Taking opioids for greater than 4 days per week prior to screening
  • Has a history of advanced renal disease or severe liver disease (within the last 6 months)
  • Receiving emicizumab while also receiving activated prothrombin complex concentrate (FEIBA)
  • Uncontrolled or poorly controlled hypertension
  • History of major cardiac or cerebrovascular disease
  • History of an upper GI perforation, obstruction, or major GI bleed or current evidence of GI bleeding
  • Has active hepatitis C or hepatitis B infection or uncontrolled HIV. Note: Patients who are HIV positive are allowed to participate if considered to be controlled.
  • Has a positive drug screen for all prohibited drugs of potential abuse at screening
  • Has had an intra-articular injection (within 3 months), initiated physical therapy (within 30 days) or has had orthopedic surgery (within 4 months) prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRM-201 (Rofecoxib)
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
Drug: TRM-201 (Rofecoxib)
Eligible patients will be randomized to receive TRM-201 or placebo
Other Names:
  • Placebo
Placebo Comparator: Placebo
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
Drug: Placebo
Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tremeau Pharmceuticals, Inc.

Investigators

  • Study Director: Judith Boice, PhD, Tremeau Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Actual)

September 28, 2022

Study Completion (Actual)

September 28, 2022

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRM-201-HA-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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