EUCTR2020-003602-31-PL进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •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
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
- •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
研究者
相似试验
进行中（未招募）
不适用
Study of the safety and effectiveness of two doses of investigational study drug EVP-6124 in subjects with Alzheimer’s DiseaseEUCTR2013-002653-30-ITEnVivo Pharmaceuticals, Inc.790
进行中（未招募）
不适用
Efficacy and Safety of REGN727/SAR236553 Versus Placebo in Patients with Heterozygous Familial Hypercholesterolemia Not Adequately Controlled with Their Lipid-Modifying TherapyEUCTR2012-001222-95-NLRegeneron Pharmaceuticals Inc.250
已完成
3 期
Once-A-Day Pregabalin For Partial SeizuresCTRI/2011/08/001976Pfizer Limited264
进行中（未招募）
1 期
Research study to evaluate SEP-4199 (the study drug) for the Treatment of Depressive Episodes in patients with Bipolar I Disorder.EUCTR2018-000103-16-BGSUNOVION PHARMACEUTICALS INC.341
进行中（未招募）
1 期
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With AlirocumabMedDRA version: 19.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersAcute coronary syndromeEUCTR2011-005698-21-EEsanofi-aventis Recherche & Développement18,600