A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)
研究概览
简要总结
This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase II clinical trial and aimed at osteoarthritis of the knee.
Patients who signed informed consent voluntarily and eligible for this study are assigned randomly to one of 3 groups after 2 week-Washout period.
- st group (experimental) : WIN-34B 450mg BID
- nd group (experimental) : WIN-34B 900mg BID
- rd group (Comparator) : Placebo BID
Patients will take WIN-34B or Placebo BID for 12 weeks. Based on baseline, after 4 weeks(Visit 3) and 12 weeks(Visit 5), Researchers check patients' physical examination, questionnaire, laboratory experiment.
After 8 weeks(Visit 4), researchers check adverse effects and current medication status via telephone interview.
After 12 weeks(Visit 5) patients stop taking drugs and after 16 weeks(Visit 6) researchers check patients' physical examination, questionnaire, adverse effects and current medication status.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between 35 and 80 years of age
- •Diagnosed with Osteoarthritis of the knee at least 3 months
- •Diagnosed with Osteoarthritis of the knee, based on ACR criteria
- •Able to communicate with researchers and write questionnaires
- •At the screening visit, checking 100mm Pain VAS at least 80mm
- •At randomization(Visit 2), checking 100mm Pain VAS over 50mm
- •Agreeing to participate and signing informed consent voluntarily
排除标准
- •Previous intra-articular injection on knee within 3 months
- •Previous knee surgery within 6 months or scheduled procedures
- •Other diseases that could affect or interfere with the therapeutic outcomes
- •Experiencing habitual use of psychotropic, narcotic analgesic drugs over 1 week
- •Diagnosed with gastrointestinal diseases, unable to stop medicines during the study
- •At the screening visit, identified liver dysfunction
- •At the screening visit, identified renal dysfunction
- •Patients who cannot take NSAIDs
- •Pregnancy and breast-feeding (women of childbearing age need pregnancy test)
- •Physicological or mental disorders, including drug-takers
- •Orthopedic diseases that could affect or interfere with the therapeutic outcomes
- •Inappropriate for the study
研究组 & 干预措施
1st group : WIN-34B 900mg
Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks
干预措施: WIN-34B (Drug)
2nd group : WIN-34B 1800mg
Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks
干预措施: WIN-34B (Drug)
3rd group : Placebo
Patients assigned to 3rd group take Placebo BID for 12weeks
干预措施: Placebo (Drug)
结局指标
主要结局
KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)
时间窗: Changes from baseline at 4, 12, 16weeks
次要结局
- Safety(Vital sign, Physical examination, Laboratory experiment, ECG, Adverse event)(Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) - There are some differences in subgroup at every visit)
- Pain VAS 100mm(Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks))
- LFI(Lequesne's Functional Index)(Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks))
- Dose and Frequency of Rescue drug(Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks))
- KHAQ(Korean Health Assessment Questionnaire)(Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks))
- Nine Point Scale(Visit5(12weeks))
- Cold-Heat Questionnaire(Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks))
研究者
Park Dong-Suk
Professor
Kyunghee University Medical Center