NCT03067194已完成4 期
Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Celecoxib 200mg Capsule QD and Celecoxib 100mg BID in Hand Osteoarthritis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients.
详细描述
This is a six-weeks, open-label, multi-center, randomized study. Patients take Celecoxib 200mg capsule once a day or Celecoxib 100mg capsules twice per day. If patients do not tolerate the pain, they are able to take Acetaminophen as a rescue medication during 6 weeks.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agreement with written informed consent and 19 years of age and older
- •Patients history of OA of hand according to ACR criteria
- •The 100mm Pain VAS is over 40mm
排除标准
- •History of OA of hand surgery
- •Intra-articular injections within 3 months
- •History of OA of hand infections within 3 months
- •Who had taken a drug that has a control of result in clinical trial by investigator's decision
- •Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods
- •clinically significant hepatic, renal, cardiovascular diseases
- •Any history of adverse reaction to the study drugs
- •Patients with gastrointestinal ulcers or bleeding disorders
- •Finger joint injury within 6 months
- •Who had following results after examination
- •K ≥ 5.5mEq/L
- •eGFR ≤ 30ml/min/1.73m^2
- •Patients on any other clinical trial or experimental treatment in the past 3 months
- •Taking narcotic analgesics or patches
- •History of drug abuse or alcoholism
- •Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
- •An impossible one who participates in clinical trial by investigator's decision
研究组 & 干预措施
Celecoxib 100mg
Active Comparator
Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks
干预措施: Celecoxib 100 MG (Drug)
Celecoxib 200mg
Active Comparator
Celecoxib 200mg, Oral, QD(once daily), During 6 weeks
干预措施: Celecoxib 200mg (Drug)
结局指标
主要结局
The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group
时间窗: baseline, 6weeks
次要结局
- Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group(baseline, 6weeks)
- The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group(baseline, 6weeks)
- Total score change of insomnia severity at 6 weeks relative to the baseline value of each group(baseline, 6weeks)
- Total dosing days of acetaminophen for 6 weeks in each group(6weeks)
- The total dose of acetaminophen for 6 weeks in each group(6weeks)
- Percentage of subjects using acetaminophen for 6 weeks in each group(6weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and IbuprofenOsteoarthritis, KneeNCT00638807Pfizer's Upjohn has merged with Mylan to form Viatris Inc.388
已完成
4 期
Effect of Celecoxib on Markers of Vascular InflammationHypertension and Coronary Artery DiseaseNCT00471341University of Florida75
已完成
2 期
Celecoxib to Treat Macular Degeneration in Patients Receiving Photodynamic TherapyMacular DegenerationNCT00043680National Eye Institute (NEI)60
进行中（未招募）
3 期
Study of Efficacy of Different Treatment Regimens of OlokizumabCOVID-19NCT05187793R-Pharm198
终止
4 期
Celebrex Total Knee Arthroplasty StudyPainOsteoarthritisNCT00359151Pfizer's Upjohn has merged with Mylan to form Viatris Inc.22