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

November 13, 2018 updated by: Lynk Biotechnologies Pte Ltd

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 208533
        • T&T Family Heath Clinic and Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention
Experimental: Test group
single dose (2g), topical application of Transdermal Glucosamine Cream (containing 10% w/w of glucosamine sulfate)
Drug: Transdermal Glucosamine Cream
Other Names:
  • TGC® Plus Capsaicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of glucosamine in synovial fluid
Time Frame: 1 to 3 hours post-intervention
For the Test group
1 to 3 hours post-intervention
Concentration of glucosamine in synovial fluid
Time Frame: At baseline
For the Control group
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lynk Biotechnologies Pte Ltd

Collaborators

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

Investigators

  • Principal Investigator: Choon Meng Ting, MD, T&T Family Health Clinic and Surgery, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2016

Primary Completion (Actual)

March 10, 2017

Study Completion (Actual)

March 10, 2017

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC/CPROJ/14/15/16
  • CTC1600169 (Registry Identifier: Health Sciences Authority Singapore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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