Clinical trial NCT03743896: Transdermal Delivery of Glucosamine to the Synovial Fluid of Male and Female With Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Transdermal Delivery
Glucosamine
Synovial Fluid
Osteoarthritis
Knee
Human
Arthrocentesis
Lead sponsor: Lynk Biotechnologies Pte Ltd
Sponsor class: INDUSTRY
Collaborators: name: T&T Family Health Clinic and Surgery, Singapore
name: Temasek Polytechnic School of Applied Science, Singapore
First posted: 2018-11-16
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects who agreed to participate in the study could decide to be part of the Control group (no intervention) or the Test group (single dose, topical application of Transdermal Glucosamine Cream)
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Concentration of glucosamine in synovial fluid
timeFrame: 1 to 3 hours post-intervention
measure: Concentration of glucosamine in synovial fluid
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: T&T Family Heath Clinic and Surgery
Study officials:
affiliation: T&T Family Health Clinic and Surgery, Singapore
name: Choon Meng Ting, MD
role: PRINCIPAL_INVESTIGATOR
References: