A Randomized, Single blind, Prospective, Multi-center, Phase II, Clinical Study to Evaluate Efficacy and Safety of Three Different Topical Formulations in Subjects Suffering from Osteoarthritis of Knee(s) and Backache.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- 1). Assessment of Knee Joint Pain and Backache on VAS
研究概览
简要总结
Thisis a Randomized, Single blind, Prospective, Multi-center, Phase II, ClinicalStudy to Evaluate Efficacy and Safety of Three Different Topical Formulationsin Subjects Suffering from Osteoarthritis of Knee(s) and Backache. The studywill be carried out in two centers in India. The study will be carried out in180 subjects (90 subjects of OA and 90 subjects of backache). Three differenttopical applications will be evaluated. All the subjects will be advised toapply sufficient quantity of given medication on index knee joint or Back twicedaily for 28 days. The primary objectives will be to assess Knee Joint Pain andBackache on VAS, to assess Knee Joint pain on WOMAC Index and to assessBackache Bournemouth questionnaire (on day 0., day 7 , day 15 and day 28). Thesecondary objectives will be to assess time of onset of action (as counterirritation) and in relieving painful symptoms, Intensity of the study drugs asa counter-irritant, Intensity of the study drugs in relieving painful symptoms,Duration of effect the study drugs as a counter irritant, Requirement of rescuemedicines, Time taken to walk a distance of 50 feet in the three study groups, overallrelief in painful symptoms by the subject and by Investigator, overallimprovement by the investigator at the end of study, Quality of life on SF -36questionnaire, Comparative evaluation of sensorial parameters and comparativesafety of study drugs (on day 0., day 7 , day 15 and day 28)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Pain in one or both knee joints due to OA for a minimum of six months and maximum for five years •Low Back Pain without any serious medical/surgical condition for a minimum period of six months.
- •â€¢History of knee pain or Low Back Pain requiring the use of NSAIDs Acetaminophen, or another analgesic agent on a regular basis for at least six months before the screening visit •OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s) •Subjects not having knee or severe Lumbar joint deformity •Subjects signing written informed consent and ready to comply with the protocol requirement •Subjects with pain VAS greater than 40 mm on weight bearing activities.
排除标准
- •â€¢Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease •Use of any analgesics except the study medication or paracetamol •Use of systemic corticosteroids within 2 months of screening, or intraarticular viscosupplementation within the past 3 months •Use of any other investigational drug within 1 month prior to randomization •Subjects having uncontrolled diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease •Known other active and serious medical or surgical disease •Pregnancy and Lactation.
- •â€¢Known hypersensitivity to ingredients used in study drug.
结局指标
主要结局
1). Assessment of Knee Joint Pain and Backache on VAS
时间窗: Day 7, Day 14, Day 21, Day 28
2). Assessment of Knee Joint pain on WOMAC Index
时间窗: Day 7, Day 14, Day 21, Day 28
3) Assessment of Back ache Bournemouth questionnaire
时间窗: Day 7, Day 14, Day 21, Day 28
次要结局
- 1. Time of onset of action as counter irritation and in relieving painful symptoms(2. Intensity of the study drugs as a counter-irritant and in relieving painful symptoms)