CTRI/2015/02/005510已完成3 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
研究者
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