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临床试验/NCT03743896
NCT03743896已完成4 期

An Open Label, Single Dose, Bioavailability Study of Topical Transdermal Glucosamine Cream on the Synovial Fluid Tapped From Osteoarthritic Adult, Male and Female Human Subjects Already Undergoing Arthrocentesis

Lynk Biotechnologies Pte Ltd1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年5月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
240
试验地点
1
主要终点
Concentration of glucosamine in synovial fluid

研究概览

简要总结

Glucosamine is commonly used as a treatment for Osteoarthritis (OA). While oral administration remains the most commonly used route, topical administration could offer numerous advantages such as targeted delivery to affected joints and overcoming the negative effects of the passage of the drug through the digestive system. The objective of this study is to assess the bioavailability of glucosamine in the synovial fluid of osteoarthritic joints, following the topical application of a commercially available transdermal glucosamine cream. Joint fluid samples will be collected from 2 groups of participants with knee OA: the Control group will not be subjected to any treatment while the Test group will apply 2g of transdermal glucosamine cream 1 to 3 hours before the joint fluid collection. Glucosamine concentration will be determined and the results obtained from both groups will be compared. This trial will potentially provide data to support that glucosamine can cross the skin and be delivered to the affected joint fluid when formulated in a transdermal cream base.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

盲法说明

There is no possibility of subjective bias or placebo effect since the primary outcome is the drug concentration in the synovial fluid. Hence no blinding or randomization needed.

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and non-pregnant female human subjects
  • 21 to 80 years old
  • Subjects who need to undergo arthrocentesis (prescribed during prior medical assessment)
  • Willingness to follow the protocol requirements

排除标准

  • Known allergy to shellfish
  • Known history of hypersensitivity to Glucosamine or related drugs.
  • Known history of hypersensitivity to Capsaicin (Capsicum extract)
  • Known history of skin sensitivity
  • Subjects who have taken any kind of glucosamine during the last 24 hours
  • Subjects who have taken any kind of treatment for joint pain during the last 24 hours
  • Subjects having scars/cut/dermatological abnormality at application site
  • Pregnant or nursing women

研究组 & 干预措施

Test group

Experimental

single dose (2g), topical application of Transdermal Glucosamine Cream (containing 10% w/w of glucosamine sulfate)

干预措施: Transdermal Glucosamine Cream (Drug)

结局指标

主要结局

Concentration of glucosamine in synovial fluid

时间窗: At baseline

For the Control group

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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