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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 45
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: TRM-201 (Rofecoxib) (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: 12 weeks
次要结局
未报告次要终点