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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04684511




Registration number
NCT04684511
Ethics application status
Date submitted
21/12/2020
Date registered
24/12/2020
Date last updated
27/10/2022

Titles & IDs
Public title
Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy
Scientific 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
Secondary ID [1] 0 0
TRM-201-HA-301
Universal Trial Number (UTN)
Trial acronym
RESET-HA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemophilic Arthropathy 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TRM-201 (Rofecoxib)
Treatment: Drugs - Placebo

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


Treatment: Drugs: TRM-201 (Rofecoxib)
Eligible patients will be randomized to receive TRM-201 or placebo

Treatment: Drugs: Placebo
Matching Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 weeks

Eligibility
Key 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
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2022
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Waratah
Recruitment postcode(s) [2] 0 0
- Murdoch
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Canada
State/province [14] 0 0
Newfoundland and Labrador
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Italy
State/province [16] 0 0
Bologna
Country [17] 0 0
Italy
State/province [17] 0 0
Roma
Country [18] 0 0
Poland
State/province [18] 0 0
Poznan
Country [19] 0 0
Poland
State/province [19] 0 0
Wroclaw
Country [20] 0 0
Spain
State/province [20] 0 0
Asturias
Country [21] 0 0
Turkey
State/province [21] 0 0
Adana
Country [22] 0 0
Turkey
State/province [22] 0 0
Antalya
Country [23] 0 0
Turkey
State/province [23] 0 0
Edirne
Country [24] 0 0
Turkey
State/province [24] 0 0
Gaziantep
Country [25] 0 0
Turkey
State/province [25] 0 0
Istanbul
Country [26] 0 0
Turkey
State/province [26] 0 0
Izmir
Country [27] 0 0
Turkey
State/province [27] 0 0
Samsun
Country [28] 0 0
Ukraine
State/province [28] 0 0
Dnipro
Country [29] 0 0
Ukraine
State/province [29] 0 0
Kharkiv
Country [30] 0 0
Ukraine
State/province [30] 0 0
Kyiv
Country [31] 0 0
Ukraine
State/province [31] 0 0
Lviv
Country [32] 0 0
Ukraine
State/province [32] 0 0
Poltava
Country [33] 0 0
Ukraine
State/province [33] 0 0
Ternopil'
Country [34] 0 0
Ukraine
State/province [34] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tremeau Pharmceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04684511
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Judith Boice, PhD
Address 0 0
Tremeau Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04684511