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Completed

NCT Number: NCT03743896

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

T&T Family Heath Clinic and Surgery

Singapore, 208533

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdermal Glucosamine Cream

Drug

Other names: TGC® Plus Capsaicin

Primary outcomes

  1. Concentration of glucosamine in synovial fluid

    Time frame: 1 to 3 hours post-intervention

    For the Test group

  2. Concentration of glucosamine in synovial fluid

    Time frame: At baseline

    For the Control group

Sponsors and collaborators

Lead sponsor

Lynk Biotechnologies Pte Ltd

Industry

Collaborators

  • T&T Family Health Clinic and Surgery, Singapore
  • Temasek Polytechnic School of Applied Science, Singapore

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 16, 2018
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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