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

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Transdermal Glucosamine Cream

• Registration Number: NCT03743896
• Lead Sponsor: Lynk Biotechnologies Pte Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-18
• Primary Completion: 2017-03-10
• Study Completion: 2017-03-10
• Status Verified: 2018-11
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-16
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Concentration of glucosamine in synovial fluid	At baseline	For the Control group

Trial Locations

Locations (1)

T&T Family Heath Clinic and Surgery; 🇸🇬 Singapore, Singapore