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

Primary Purpose

Hemophilic Arthropathy

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TRM-201 (Rofecoxib)
Placebo
Sponsored by
Tremeau Pharmceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilic Arthropathy focused on measuring Hemophilia, Pain, HA, Joint Pain

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center
  • Center for Inherited Blood Disorders
  • UC Davis Children's Hospital
  • University of Colorado Hemophilia & Thrombosis Center
  • Georgetown University Hospital - Medstar
  • University of Florida - Shands
  • Clinical Trial Services, Corp
  • Anchor Medical Research, LLC
  • Rush University Medical Center
  • University of Iowa Hospitals & Clinics
  • Louisiana Center for Bleeding and Clotting Disorders
  • Johns Hopkins University
  • ECMC Hospital
  • Icahn School of Medicine at Mount Sinai.
  • East Carolina University
  • Rainbow Babies and Children's Hospital
  • Oregon Health & Science University
  • North Texas Comprehensive Hemophilia Center
  • Gulf States Hemophilia and Thrombophilia Center
  • Calvary Mater Newcastle
  • Fiona Stanley Hospital
  • The Alfred Hospital
  • Health Sciences Center
  • Hamilton Health Sciences Centre
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Ospedale Pediatrico Bambino Gesù
  • Centrum Medyczne Pratia Poznan
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Hospital Universitario Central de Asturias
  • Acibadem Adana Hospital
  • Akdeniz University Medical Faculty
  • Erciyes University Medical Faculty
  • Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Ege University Medical Faculty
  • Ege University Medical Faculty
  • Ondokuz Mayis Univ. Med. Fac.
  • CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC
  • CI of Healthcare Kharkiv City Clin Children's Hosp #16 Kharkiv NMU
  • Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
  • Kyiv CCH #9 City SPC of Diagnostics & Treatment of Patients with HP
  • Nat.Children Specialized Hosp.OKHMATDYT of the Ministry of Health of Ukraine
  • SI Institute of Blood Pathology and Transfusion Medicine of NAMSU
  • M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy
  • CI of TRC Ternopil UH
  • CI Zaporizhzhya Regional Clinical Hospital of ZRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TRM-201 (Rofecoxib)

Placebo

Arm Description

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

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2020
Last Updated
October 25, 2022
Sponsor
Tremeau Pharmceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04684511
Brief Title
Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy
Acronym
RESET-HA
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment. The termination of the trial was not based on any safety concerns in the study.
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tremeau Pharmceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilic Arthropathy
Keywords
Hemophilia, Pain, HA, Joint Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRM-201 (Rofecoxib)
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
TRM-201 (Rofecoxib)
Other Intervention Name(s)
Placebo
Intervention Description
Eligible patients will be randomized to receive TRM-201 or placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Boice, PhD
Organizational Affiliation
Tremeau Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Orthopedic Hospital DBA Orthopedic Hemophilia Treatment Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Facility Name
Center for Inherited Blood Disorders
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Davis Children's Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Hemophilia & Thrombosis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Hospital - Medstar
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Florida - Shands
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Clinical Trial Services, Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Anchor Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Louisiana Center for Bleeding and Clotting Disorders
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
ECMC Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai.
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
North Texas Comprehensive Hemophilia Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Gulf States Hemophilia and Thrombophilia Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Health Sciences Center
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
NL A1B3V6
Country
Canada
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
Country
Italy
Facility Name
Ospedale Pediatrico Bambino Gesù
City
Roma
Country
Italy
Facility Name
Centrum Medyczne Pratia Poznan
City
Poznań
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wrocław
Country
Poland
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Acibadem Adana Hospital
City
Adana
Country
Turkey
Facility Name
Akdeniz University Medical Faculty
City
Antalya
Country
Turkey
Facility Name
Erciyes University Medical Faculty
City
Edirne
Country
Turkey
Facility Name
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
City
Istanbul
Country
Turkey
Facility Name
Ege University Medical Faculty
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Ege University Medical Faculty
City
İzmir
Country
Turkey
Facility Name
Ondokuz Mayis Univ. Med. Fac.
City
Samsun
Country
Turkey
Facility Name
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC
City
Dnipro
Country
Ukraine
Facility Name
CI of Healthcare Kharkiv City Clin Children's Hosp #16 Kharkiv NMU
City
Kharkiv
Country
Ukraine
Facility Name
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
City
Kyiv
Country
Ukraine
Facility Name
Kyiv CCH #9 City SPC of Diagnostics & Treatment of Patients with HP
City
Kyiv
Country
Ukraine
Facility Name
Nat.Children Specialized Hosp.OKHMATDYT of the Ministry of Health of Ukraine
City
Kyiv
Country
Ukraine
Facility Name
SI Institute of Blood Pathology and Transfusion Medicine of NAMSU
City
Lviv
Country
Ukraine
Facility Name
M.V. Sklifosovskyi Poltava RCH Dept of Pulmonology HSEIU Ukrainian Medical Stomatological Academy
City
Poltava
Country
Ukraine
Facility Name
CI of TRC Ternopil UH
City
Ternopil'
Country
Ukraine
Facility Name
CI Zaporizhzhya Regional Clinical Hospital of ZRC
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy

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