NCT06595004已完成3 期
A Randomized, Double-blind, Active-controlled, Non-inferiority, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HCP1004 as Compared to RLD2401 in Chronic Low-Back Pain Patients
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2024年11月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Change from baseline in VAS
研究概览
简要总结
A Randomized, Double-blind, Active-controlled, Non-inferiority, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HCP1004 as compared to RLD2401 in Chronic Low-Back Pain Patients
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic low back pain ≥3 months in duration
- •Quebec Task Force in Spinal Disorders class 1 or 2
- •Male or female ≥ 19 years of age with following criteria:
- •≥ 50 years
- •19~ 49 years with history of gastric or duodenal ulcers within the past 5 years
- •Low back pain disease condition expected to require daily NSAIDs therapy for at least 12 weeks
- •VAS ≥ 40 (at Visit 2) (If there are any treatment history to affect the efficacy evaluation of low back pain, VAS after washout period have to meet the criteria; 20% over baseline VAS or change from baseline VAS ≥10)
排除标准
- •Diagnosed with certain serious diseases that may be secondary causes of Low back pain (e.g., tumors, infectious diseases, gout, etc.)
- •Clinically significant neurological disease or low back pain due to trauma (e.g. spinal fracture) within the past 6 months
- •Invasive procedures (using corticosteroids) in the lumbar region within the past 3 months or surgical intervention within the past 6 months or need to such interventions during the study
- •History of non-drug treatment of the lumbar region (e.g., physical therapy) for the purpose of alleviating low back pain within 7 days prior to the screening visit.
- •Active gastritis, inflammatory bowel syndrome, peptic ulcer or any history of gastrointestinal bleeding duodenal ulceration within the past 3 months
- •Patients with history of platelet-related disease or bleeding disorder within the past 6 months or who are taking anti-coagulants
- •Patients with ischemic heart disease or severe cerebrovascular disease within the past 6 months
- •Bronchial asthma or Uncontrolled Diabete Mellitus or Hypertension
- •Use of peptic ulcer treatment (H2-blockers, PPI, PCAB series or Misoprostol), psychotropic drugs, narcotic analgesics or systemic corticosteroids within past 4 weeks
- •Severe renal dysfunction (Creatinine clearance ≥ 30mL/min ) or Severe liver dysfunction (AST or AST ≥ 3 x UNL)
- •History of malignant tumors within past 5 years
- •Positive to pregnancy test, nursing mother, intention on pregnancy
- •Considered by investigator as not appropriate to participate in the study with other reason
研究组 & 干预措施
Experimental 1
Experimental
Take HCP1004 twice daily for 12 weeks orally.
干预措施: HCP1004 (Drug)
Active Comparator
Active Comparator
Take RLD2401 twice daily for 12 weeks orally.
干预措施: RLD2401 (Drug)
结局指标
主要结局
Change from baseline in VAS
时间窗: 4 weeks
次要结局
- Change from baseline in VAS(Visual Analog Scale)(8 weeks, 12 weeks)
- Change from baseline in ODI(Oswestry Disability Index) Score(4 weeks, 8 weeks, 12 weeks)
- Change from baseline in EQ-5D Score(4 weeks, 8 weeks, 12 weeks)
- Change from baseline in GSRS(Gastrointestinal Symptom-Rating Scale) Score(4 weeks, 8 weeks, 12 weeks)
- Usage of rescue medicine(4 weeks, 8 weeks, 12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus CutaneusPruritusNCT03317301Hanlim Pharm. Co., Ltd.189
已完成
3 期
Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 TrialGlabellar LinesNCT05804656CKD Bio Corporation300
进行中（未招募）
3 期
TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular DegenerationNeovascular Age-related Macular DegenerationNCT05461339TOT Biopharm Co., Ltd.488
已完成
3 期
Safety and Efficacy of Brexpiprazole in the Treatment of SchizophreniaSchizophreniaNCT03874494Otsuka Beijing Research Institute371
已完成
3 期
A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With GastritisAcute GastritisChronic GastritisNCT04189705Korea Otsuka Pharmaceutical Co., Ltd.392