Double Blinded, Randomized, Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- 100mm Pain VAS reduction
研究概览
简要总结
The objective of this study was to to evaluate the efficacy and safety of PG201 in osteoarthritis patients.
This clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%. Assuming 20% drop-out rate, the number of subjects required for each treatment group was estimated to be 154, while the total number of subjects required for the study 308.
non-inferiority margin: 8mm
详细描述
Patients in the PG201 group were prescribed two PG201 tablets per day(BID) and one celecoxib placebo capsule each in the morning and evening per day for 8 weeks.
Patients in the celecoxib group were prescribed celecoxib 200 mg (one 200 mg capsule and one celecoxib placebo capsule) and one PG201 placebo tablet each in the morning and evening per day for 8 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥40 and ≤ 80years of age.
- •Patients who meet the American College of Rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow:
- •a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings.
- •Age> 50 years.
- •Morning stiffness for less than 30 minutes.
- •Crepitus during movement of the weight-bearing knee.
- •Patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.
- •Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening.
- •Patients who had a score of 100mm pain VAS ≤80 mm at screening.
- •Patients who had a score of 100mm pain VAS ≥50 mm at baseline.
- •Patients should be able and willing to provide the written informed consent.
排除标准
- •Patients with a history of surgery or arthroscopy of the study joint within the previous 6 months.
- •Patients with trauma of study joint within the previous 12 months.
- •Patients with symptomatic hip osteoarthritis, other condition that would interfere with study assessments.
- •Patients with any other type of arthritis, active malignancies or any active GI, cardiovascular, renal, hepatic, neurologic, or psychiatric disease.
- •Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
- •Patients with uncontrollable hypertension.
- •Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate aminotransferase > 1.5 times the Upper Lange of normal at screening.
- •Patients with a history of drug or alcohol abuse.
研究组 & 干预措施
PG201 tablet
干预措施: PG201 tablet (Drug)
Celecoxib capsule
干预措施: Celebrex capsule (Drug)
结局指标
主要结局
100mm Pain VAS reduction
时间窗: Screening, Day1, Day28
次要结局
- The responder index (RI)(screening, Day1, Day28)
- The change in the patient self-assessed & investigator-assessed overall symptom scores(Screening, Day1, Day28)
- Pain VAS total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Screening, Day1, Day28)
- Sub-scale score and total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Screening, Day1, Day28)
- The change in the quality of life score(Day1, Day28)