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

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ClinicalTrials.gov Identifier: NCT04684511
Recruitment Status : Not yet recruiting
First Posted : December 24, 2020
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Tremeau Pharmceuticals, Inc.

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
Hemophilic Arthropathy Drug: TRM-201 (Rofecoxib) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

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 Name: 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




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. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684511


Contacts
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Contact: Mary Garfield, MBA 2039065693 Mary.Garfield@tremeaurx.com

Locations
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Sponsors and Collaborators
Tremeau Pharmceuticals, Inc.
Investigators
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Study Director: Judith Boice, PhD Tremeau Pharmaceuticals
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Responsible Party: Tremeau Pharmceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04684511    
Other Study ID Numbers: TRM-201-HA-301
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: January 2021

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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:
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Rofecoxib
Joint Diseases
Musculoskeletal Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents