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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743896
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
T&T Family Health Clinic and Surgery, Singapore
Temasek Polytechnic School of Applied Science, Singapore
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Transdermal Glucosamine Cream Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Masking Description: There is no possibility of subjective bias or placebo effect since the primary outcome is the drug concentration in the synovial fluid. Hence no blinding or randomization needed.
Primary Purpose: Basic Science
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
Actual Study Start Date : May 18, 2016
Actual Primary Completion Date : March 10, 2017
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: TGC® Plus Capsaicin




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743896


Locations
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Singapore
T&T Family Heath Clinic and Surgery
Singapore, Singapore, 208533
Sponsors and Collaborators
Lynk Biotechnologies Pte Ltd
T&T Family Health Clinic and Surgery, Singapore
Temasek Polytechnic School of Applied Science, Singapore
Investigators
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Principal Investigator: Choon Meng Ting, MD T&T Family Health Clinic and Surgery, Singapore
  Study Documents (Full-Text)

Documents provided by Lynk Biotechnologies Pte Ltd:
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Responsible Party: Lynk Biotechnologies Pte Ltd
ClinicalTrials.gov Identifier: NCT03743896    
Other Study ID Numbers: ASC/CPROJ/14/15/16
CTC1600169 ( Registry Identifier: Health Sciences Authority Singapore )
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lynk Biotechnologies Pte Ltd:
Transdermal Delivery
Glucosamine
Synovial Fluid
Osteoarthritis
Knee
Human
Arthrocentesis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs