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临床试验/NCT00108992
NCT00108992已完成3 期

Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis

Nuvo Research Inc.44 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2004年2月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
750
试验地点
44
主要终点
pain

研究概览

简要总结

Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.

详细描述

During this 12-week study, patients will visit the study clinic 5 times. At the screening visit, the patient's demographic information, medical and medication history will be recorded and a physical examination performed. After washout of all NSAIDs/other analgesic medication, the patient will return for the baseline visit. During the treatment phase of the study, the patient will apply a topical solution to his/her osteoarthritic knee and take an oral study tablet. The patient may randomly receive active treatment with topical diclofenac, oral diclofenac, both, or neither (placebo). Follow-up clinic visits are conducted at 4, 8 and 12 weeks. Routine laboratory analyses are done at baseline, 4 and 12 weeks.

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

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary osteoarthritis of the knee, verified radiographically
  • Moderate flare of pain in the knee after washout of stable therapy
  • If female, non-pregnant
  • Ability to swallow moderately-sized tablets

排除标准

  • Secondary osteoarthritis of the knee
  • Major knee surgery at any time, or minor knee surgery in previous year
  • Severe uncontrolled heart, liver or kidney disease
  • Ulcer or bleeding from the stomach
  • Corticosteroid use
  • Fibromyalgia
  • Skin disorder of the knee

结局指标

主要结局

pain

physical function

patient overall health assessment

次要结局

  • patient global assessment
  • stiffness

研究者

发起方
Nuvo Research Inc.
申办方类型
Industry

研究点 (44)

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