A prospective, randomized, double blind, two arm, parallel, placebo controlled, comparative, multicentre clinical study to evaluate the safety and efficacy of Dynapar QPS compared to placebo topical solution for treatment of osteoarthritis of knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 8
- 主要终点
- • Change from baseline in WOMAC index sub score for pain
研究概览
简要总结
This study is a prospective, randomized, double blind, two arm, parallel, placebo controlled, comparative, multicentre clinical study to evaluate the safety and efficacy of Dynapar QPS (5 sprays, QID) compared to placebo (5 sprays, QID) topical solution in 212 patients with osteoarthritis of knee, that will be conducted in 8 centers in India. The primary outcome measures will be Change from baseline in WOMAC index sub score for pain on week 1, 2, 4 and 6. Change from baseline in VAS Score for pain intensity on weight bearing activity will also be assessed on week 1, 2, 4 and 6. The secondary outcome measured will be Change from baseline in the WOMAC index sub scores other than pain e.g. stiffness and physical function on week 1, 2, 4 and 6. Mean number of tablets of rescue analgesic required during the study period on week 1, 2, 4 and 6. Mean number of days for which patient required rescue analgesic during the study period on week 1, 2, 4 and 6. Proportion of patients requiring rescue analgesia for ≥ 50% (≥ 21 days) of study period. The Global assessment of efficacy by patients and investigator will be done at week 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either gender, 40-65 years of age 2.Patient fulfilling modified American College of Rheumatology (ACR) criteria for osteoarthritis of knee 3.Patients on frequent oral analgesic treatment (at least 3 days per week during the previous 4 weeks) for at least past 4 weeks for the management of symptomatic unilateral or bilateral primary osteoarthritis of knee at the time of screening 4.Patients with at least moderate intensity of pain (defined as score of greater than or equal to 4 on 10 point visual analogue scale) while performing a weight-bearing activity e.g. walking, standing, climbing stairs during or at the end of washout period after screening.
排除标准
- •1.History of major trauma or surgery in the study joint within previous 6 months at the time of screening 2.History of acute inflammatory arthritis, pseudogout or crystal deposition disorder of the study knee joint 3.Radiographic evidence suggestive of arthritis other than primary osteoarthritis 4.Patients receiving prescription muscle relaxants, psychotropic agents (except tramadol) corticosteroids or any other drug affecting the evaluation of analgesic action; or taking supplements like glucosamine and chondroitin sulfate.
- •5.Patients with alternative form of therapy i.e. physical manipulation, acupuncture etc.
- •6.Intramuscular corticosteroids in past 4 weeks or; oral or topical corticosteroids in past 2 weeks at the time of screening 7.Intra-articular injection of any drug within past 4 weeks at the time of screening 8.Patients with history of cardiovascular surgery i.e., coronary artery bypass graft or Percutaneous coronary intervention, within past 4 weeks at the time of screening 9.Patients who require or scheduled for any surgery (including knee joint surgery) during study period 10.Uncontrolled systemic disorders like diabetes mellitus, hypertension, or cardiac disorder requiring hospitalization 11.Renal or hepatic impairment as per following laboratory parameters, •Serum creatinine greater than upper limit of normal; •SGOT or SGPT greater than 3 times upper limit of normal 12.Patients requiring hospitalization during the study period 13.Skin disorder at the site of study drug application 14.Use of other topical medicines at the same site of study drug application 15.Known case of gastrointestinal bleeding or peptic ulcer disease 16.History of bronchial asthma, bronchitis or any other contraindication to study drugs 17.Known hypersensitivity to NSAIDs or history of hypersensitivity to any topical medication 18.Patients on any form of anticoagulation therapy 19.Pregnant and lactating women 20.Women of child bearing potential, not practicing or not willing to use contraceptive method during study period unless patient had undergone hysterectomy 21.Patient unwilling or incapable of giving informed consent or to comply with study procedures 22.Patients having participated in any clinical trial within last 30 days at the time of screening 23.Previous participation in this study 24.Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.
结局指标
主要结局
• Change from baseline in WOMAC index sub score for pain
时间窗: Day 1, 7, 14, 28 and 42
• Change from baseline in VAS Score for pain intensity on weight bearing activity
时间窗: Day 1, 7, 14, 28 and 42
次要结局
- Change from baseline in the WOMAC index sub scores other than pain e.g. stiffness and physical function(Day 1, 7, 14, 28 and 42)
- Mean number of tablets of rescue analgesic required during the study period(Day 1 to 42)
- Mean number of days for which patient required rescue analgesic during the study period(Day 1 to 42)
- Proportion of patients requiring rescue analgesia for greater than or equal to 50% (greater than or equal to 21 days) of study period(Day 1 to 42)
- Global assessment of efficacy by patients and investigator(Day 42)
- Change in vitals(Day 1, 7, 14, 28 and 42)
- Change in adverse events with pre-enrollment systemic analgesic therapy after initiation of study medication(Day 1)
- Local adverse events(Day 1 to 42)
- Systemic adverse events(Day 1 to 42)
- Clinical laboratory parameter abnormality(During screening and on day 42)
- Global assessment of tolerability by patients and investigator(Day 42)