NCT01779271已完成3 期
Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Changes in Body temperature from baseline
研究概览
简要总结
Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in patients with Acute upper respiratory infection.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 15 years old
- •Male and Female
- •Patients with fever over 38.0°C due to cold (acute upper respiratory tract infection)
- •Patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration
- •Subjects who voluntarily or legal guardian agreed with written consent
排除标准
- •Fever reducer administration Within 4 hours from the screening point
- •Any incidence of febrile crisis from the past six months
- •Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
- •Patients with continuously administrating gastrointestinal disorder related drug
- •Patients with severe blood damage
- •Severe hepatic impairment (ALT, AST value more than 2 times the upper limit of the normal range)
- •With severe renal impairment (serum creatinine value is more than 2 times the upper limit of the normal range)
- •Patients with severe left ventricular dysfunction
研究组 & 干预措施
Pelubiprofen
Experimental
干预措施: Pelubiprofen (Drug)
Loxoprofen
Active Comparator
干预措施: Loxoprofen (Drug)
结局指标
主要结局
Changes in Body temperature from baseline
时间窗: 0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain PatientsChronic Back PainNCT02375633Daewon Pharmaceutical Co., Ltd.166
已完成
3 期
Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis PatientsPelubiprofenCelebrexRheumatoid ArthritisNCT01781702Daewon Pharmaceutical Co., Ltd.120
已完成
3 期
Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient SurgeriesGynecological Outpatient SurgeryNCT04958746Haisco Pharmaceutical Group Co., Ltd.135
已完成
3 期
A Phase III Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or AnesthesiaSedation or AnesthesiaNCT03674008Sichuan Haisco Pharmaceutical Group Co., Ltd280
Unknown
3 期
Clinical Study in the Treatment of Patients With COVID-19COVID-19NCT04780672Pharma VAM330