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

NCT03743896 | Completed Phase 4

• 2 other identifiers: ASC/CPROJ/14/15/16CTC1600169
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Transdermal Delivery; Glucosamine; Synovial Fluid; Osteoarthritis; Knee; Human; Arthrocentesis

Outcome Measures

Primary Outcomes (2)

• Concentration of glucosamine in synovial fluid

  For the Test group

  1 to 3 hours post-intervention

• Concentration of glucosamine in synovial fluid

  For the Control group

  At baseline

Study Arms (2)

Control group

NO INTERVENTION

No intervention

Test group

EXPERIMENTAL

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

Drug: Transdermal Glucosamine Cream

Interventions

Transdermal Glucosamine Cream DRUG

Also known as: TGC® Plus Capsaicin

Test group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and non-pregnant female human subjects
• to 80 years old
• Subjects who need to undergo arthrocentesis (prescribed during prior medical assessment)
• Willingness to follow the protocol requirements

You may not qualify if:

• 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

Sponsors & Collaborators

• Lynk Biotechnologies Pte Ltd: lead
• T&T Family Health Clinic and Surgery, Singapore: collaborator
• Temasek Polytechnic School of Applied Science, Singapore: collaborator

Study Sites (1)

T&T Family Heath Clinic and Surgery

Singapore, 208533, Singapore

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Protein Glutamine gamma Glutamyltransferase 2; Capsaicin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Transglutaminases; Aminoacyltransferases; Acyltransferases; Transferases; Enzymes; Enzymes and Coenzymes; Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Choon Meng Ting, MD

  T&T Family Health Clinic and Surgery, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: May 18, 2016
• Primary Completion: March 10, 2017
• Study Completion: March 10, 2017
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

SG (1)