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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743896
• Other study ID #: ASC/CPROJ/14/15/16
• Secondary ID: CTC1600169
• Status: Completed
• Phase: Phase 4
• Start date: May 18, 2016
• Est. completion date: March 10, 2017

Study information

• Verified date: November 2018
• Source: Lynk Biotechnologies Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 10, 2017
• Est. primary completion date: March 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Transdermal Glucosamine Cream

Locations

Country	Name	City	State
Singapore	T&T Family Heath Clinic and Surgery	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Lynk Biotechnologies Pte Ltd	T&T Family Health Clinic and Surgery, Singapore, Temasek Polytechnic School of Applied Science, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of glucosamine in synovial fluid	For the Test group	1 to 3 hours post-intervention
Primary	Concentration of glucosamine in synovial fluid	For the Control group	At baseline