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临床试验/NCT00838487
NCT00838487Unknown3 期

Phase 3 Study, to Evaluate Safety & Efficacy of the Association Condroflex + Therapeutic Exercises Compared to Placebo + Therapeutic Exercises, in Subjects With Knee OA

Zodiac Produtos Farmaceuticos S.A.1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2009年3月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
240
试验地点
1
主要终点
improvement of pain

研究概览

简要总结

Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee OA and not exposed to prior treatment with the products under investigation.

详细描述

To have osteoarthritis degree 2 or 3 / To be capable to consent

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
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • to have knee osteoarthritis degree 2 or 3
  • to be capable to consent

排除标准

  • previous drug treatment
  • concomitant diseases
  • concomitant drugs

结局指标

主要结局

improvement of pain

时间窗: 12 week

次要结局

  • rigidity restriction(12 week)

研究者

发起方
Zodiac Produtos Farmaceuticos S.A.
申办方类型
Industry

研究点 (1)

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