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

Who is this study for? Pediatric and adult patients aged 12 to 75 years with hemophilic arthropathy
What treatments are being studied? TRM-201
Status: Terminated
Location: See all (46) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 75
Healthy Volunteers: No
View:

• 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

Locations
United States
California
Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center
Los Angeles
Center for Inherited Blood Disorders
Orange
UC Davis Children's Hospital
Sacramento
Colorado
University of Colorado Hemophilia & Thrombosis Center
Aurora
Washington, D.c.
Georgetown University Hospital - Medstar
Washington
Florida
University of Florida - Shands
Gainesville
Anchor Medical Research, LLC
Miami
Clinical Trial Services, Corp
Miami
Iowa
University of Iowa Hospitals & Clinics
Iowa City
Illinois
Rush University Medical Center
Chicago
Louisiana
Louisiana Center for Bleeding and Clotting Disorders
New Orleans
Maryland
Johns Hopkins University
Baltimore
North Carolina
East Carolina University
Greenville
New York
ECMC Hospital
Buffalo
Icahn School of Medicine at Mount Sinai.
New York
Ohio
Rainbow Babies and Children's Hospital
Cleveland
Oregon
Oregon Health & Science University
Portland
Texas
North Texas Comprehensive Hemophilia Center
Dallas
Gulf States Hemophilia and Thrombophilia Center
Houston
Other Locations
Australia
The Alfred Hospital
Melbourne
Fiona Stanley Hospital
Murdoch
Calvary Mater Newcastle
Waratah
Canada
Hamilton Health Sciences Centre
Hamilton
Health Sciences Center
Saint John's
Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna
Ospedale Pediatrico Bambino Gesù
Roma
Poland
Centrum Medyczne Pratia Poznan
Poznań
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wrocław
Spain
Hospital Universitario Central de Asturias
Oviedo
Turkey
Acibadem Adana Hospital
Adana
Akdeniz University Medical Faculty
Antalya
Erciyes University Medical Faculty
Edirne
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
Gaziantep
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul
Ege University Medical Faculty
İzmir
Ege University Medical Faculty
İzmir
Ondokuz Mayis Univ. Med. Fac.
Samsun
Ukraine
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC
Dnipro
CI of Healthcare Kharkiv City Clin Children's Hosp #16 Kharkiv NMU
Kharkiv
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv
Kyiv CCH #9 City SPC of Diagnostics & Treatment of Patients with HP
Kyiv
Nat.Children Specialized Hosp.OKHMATDYT of the Ministry of Health of Ukraine
Kyiv
SI Institute of Blood Pathology and Transfusion Medicine of NAMSU
Lviv
M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy
Poltava
CI of TRC Ternopil UH
Ternopil'
CI Zaporizhzhya Regional Clinical Hospital of ZRC
Zaporizhzhya
Time Frame
Start Date: June 2, 2021
Completion Date: September 28, 2022
Participants
Target number of participants: 2
Treatments
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
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
Related Therapeutic Areas
Sponsors
Leads: Tremeau Pharmceuticals, Inc.

This content was sourced from clinicaltrials.gov

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