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

Sponsor
Tremeau Pharmceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04684511
Collaborator
(none)
160
Enrollment
57
Locations
2
Arms
27.3
Anticipated Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TRM-201 (Rofecoxib)
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 24, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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. [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center Los Angeles California United States 90007
    2 Center for Inherited Blood Disorders Orange California United States 92868
    3 UC Davis Children's Hospital Sacramento California United States 95817
    4 University of Colorado Hemophilia & Thrombosis Center Aurora Colorado United States 80045
    5 Georgetown University Hospital - Medstar Washington District of Columbia United States 20007
    6 University of Florida - Shands Gainesville Florida United States 32610
    7 Clinical Trial Services, Corp Miami Florida United States 33144
    8 Clinical Trials Service, Corp. Miami Florida United States 33144
    9 Anchor Medical Research, LLC Miami Florida United States 33176
    10 Rush University Medical Center Chicago Illinois United States 60612
    11 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    12 Louisiana Center for Bleeding and Clotting Disorders New Orleans Louisiana United States 70112
    13 Johns Hopkins University Baltimore Maryland United States 21205
    14 ECMC Hospital Buffalo New York United States 14202
    15 Icahn School of Medicine at Mount Sinai. New York New York United States 10029
    16 East Carolina University Greenville North Carolina United States 27858
    17 Rainbow Babies and Children's Hospital Cleveland Ohio United States 44106
    18 Oregon Health & Science University Portland Oregon United States 97239
    19 North Texas Comprehensive Hemophilia Center Dallas Texas United States 75390
    20 Gulf States Hemophilia and Thrombophilia Center Houston Texas United States 77030
    21 Calvary Mater Newcastle Waratah New South Wales Australia
    22 Royal Adelaide Hosptial Adelaide South Australia Australia 5000
    23 Fiona Stanley Hospital Murdoch Western Australia Australia
    24 Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul Caxias Do Sul Rio Grande Do Sol Brazil
    25 Instituto Mederi de Pesquisa e Saude Passo Fundo Rio Grande Do Sul Brazil
    26 FM-UFPel - Faculdade de Medicina da Universidade Federal de Pelotas Pelotas Rio Grande Do Sul Brazil
    27 Complexo Hospitalar Edmundo Vasconcelos São Paulo Brazil
    28 Health Sciences Center Saint John's Newfoundland and Labrador Canada NL A1B3V6
    29 Hamilton Health Sciences Centre Hamilton Ontario Canada
    30 Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Bologna Italy
    31 Ospedale Pediatrico Bambino Gesù Roma Italy
    32 Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino Italy
    33 Ospedale San Bortolo di Vicenza Vicenza Italy
    34 Centrum Medyczne Pratia Poznan Poznań Poland
    35 Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wrocław Poland
    36 Territorial Clinical Hospital Barnaul Russian Federation
    37 Kemerovo Regional Clinical Hospital Kemerovo Russian Federation
    38 Medis Nizhny Novgorod Russian Federation
    39 Clinical Oncology Dispensary Omsk Russian Federation 644013
    40 Samara State Medical University Samara Russian Federation
    41 Acibadem Adana Hospital Adana Turkey
    42 Akdeniz University Medical Faculty Antalya Turkey
    43 Erciyes University Medical Faculty Edirne Turkey
    44 Gaziantep University Medical Faculty Sahinbey Educational Research Hospital Gaziantep Turkey 27310
    45 Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Istanbul Turkey
    46 Ege University Medical Faculty İzmir Turkey 35100
    47 Ege University Medical Faculty İzmir Turkey
    48 Ondokuz Mayis Univ. Med. Fac. Samsun Turkey
    49 CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dnipro Ukraine
    50 CI of Healthcare Kharkiv City Clin Children's Hosp #16 Kharkiv NMU Kharkiv Ukraine
    51 Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital Kyiv Ukraine
    52 Kyiv CCH #9 City SPC of Diagnostics & Treatment of Patients with HP Kyiv Ukraine
    53 Nat.Children Specialized Hosp.OKHMATDYT of the Ministry of Health of Ukraine Kyiv Ukraine
    54 SI Institute of Blood Pathology and Transfusion Medicine of NAMSU Lviv Ukraine
    55 M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy Poltava Ukraine
    56 CI of TRC Ternopil UH Ternopil' Ukraine
    57 CI Zaporizhzhya Regional Clinical Hospital of ZRC Zaporizhzhya Ukraine

    Sponsors and Collaborators

    • Tremeau Pharmceuticals, Inc.

    Investigators

    • Study Director: Judith Boice, PhD, Tremeau Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tremeau Pharmceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04684511
    Other Study ID Numbers:
    • TRM-201-HA-301
    First Posted:
    Dec 24, 2020
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tremeau Pharmceuticals, Inc.
    Hemophilia
    Pain
    HA
    Joint Pain
    Additional relevant MeSH terms:
    Joint Diseases
    Rofecoxib

    Study Results

    No Results Posted as of Jun 28, 2022