Trial | NCT03743896  Report issue

Title

Transdermal Delivery of Glucosamine to the Synovial Fluid of Male and Female With Knee Osteoarthritis
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    240
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.
Study Started
May 18
2016
Primary Completion
Mar 10
2017
Study Completion
Mar 10
2017
Last Update
Nov 16
2018

Drug Transdermal Glucosamine Cream

  • Other names: TGC® Plus Capsaicin

Control group No Intervention

No intervention

Test group Experimental

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted