跳至主要内容
临床试验/NCT00110474
NCT00110474已完成3 期

Efficacy and Safety of Glucosamine Sulfate Versus a Pure Analgesic (Acetaminophen/Paracetamol) and Placebo in Patients Suffering From Osteoarthritis of the Knee

Rottapharm16 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2000年5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
Rottapharm
入组人数
300
试验地点
16
主要终点
Lequesne Index

研究概览

简要总结

The primary objective of this study is to evaluate the efficacy and safety of glucosamine sulfate versus placebo on the symptoms of knee osteoarthritis after 6 months of treatment, using acetaminophen as a reference symptomatic medication.

详细描述

Osteoarthritis is a common degenerative joint disease, affecting a large proportion of the general population. Its severity is progressive and often requires long-term treatment courses.

Medications for osteoarthritis may affect symptoms (pain and function limitation) and/or modify joint structure.

Pharmacological agents usually employed to treat symptoms generally include unspecific drugs such as pure analgesics and non-steroidal antiinflammatory drugs (NSAIDs), as well as compounds that are possibly disease specific, since they probably interact with some of the osteoarthritis pathogenetic factors: glucosamine sulfate is one of these agents.

Glucosamine sulfate has recently attracted the attention of the scientific community and of patients, because two long-term (3 years) clinical trials in comparison with placebo, showed that this is the first agent able to retard the progression of anatomic joint structure changes in knee osteoarthritis, besides controlling the progression of symptoms.

Earlier studies had shown that glucosamine sulfate is effective in relieving the symptoms of osteoarthritis also over shorter treatment courses (few weeks or months), in comparison with placebo. In addition, glucosamine sulfate efficacy in short studies was at least comparable to that of unspecific symptomatic medications such as conventional NSAIDs, whilst being better tolerated. However, all practice guidelines for the treatment of osteoarthritis suggest acetaminophen (paracetamol) as the oral analgesic to try first and, if successful, the preferred long-term symptomatic medication.

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
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of knee osteoarthritis according to the clinical and radiological criteria of the American College of Rheumatology (ACR), with minimum symptom severity/characteristics

排除标准

  • Standard exclusions apply

结局指标

主要结局

Lequesne Index

次要结局

  • WOMAC Index
  • OARSI Responder Criteria

研究者

发起方
Rottapharm
申办方类型
Industry

研究点 (16)

Loading locations...

相似试验