Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- The primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index.
研究概览
简要总结
Abstract
Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee.
A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
详细描述
The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health status measure. It probes clinically important patient relevant symptoms in the areas of pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. It consists of 24 questions in three separated subscales (5 questions on pain subscale, 17 questions on physical function subscales and 2 questions on stiffness subscale), each scored in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain). Each subscale score was weighed 10 points, thus 30 was the maximum punctuation for WOMAC total score.
The Lequesne index is a 10-question interview-style survey given to patients with osteoarthritis of the knee. It has 5 questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and 4 questions about daily activities. The total questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional impairment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 40 years
- •symptomatic evidence of OA in the knee for at least 1 year
- •radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee
- •no intra-articular injection of corticosteroids within the last 3 months
排除标准
- •any history of adverse reaction to the study drugs
- •current pregnancy status
- •uncontrolled hypertension
- •active infection
- •undergone surgery/arthroscopy within three months
- •diagnosis of radiographic OA of Kellgren and Lawrence grade I
研究组 & 干预措施
kondrium
intraarticular injections once month
干预措施: kondrium (Drug)
kondrium f
干预措施: kondrium f (Drug)
corticosteroid
intraarticular injections once month
干预措施: methyl prednisolone (corticosteroid) (Drug)
结局指标
主要结局
The primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index.
时间窗: 4 months
次要结局
未报告次要终点