Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy

Phase 1

• Conditions: Hemophilic Arthropathy; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2020-003602-31-PL
• Lead Sponsor: Tremeau Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-03
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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 5 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified