- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743896
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
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Singapore, Singapore, 208533
- T&T Family Heath Clinic and Surgery
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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
|
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Experimental: Test group
single dose (2g), topical application of Transdermal Glucosamine Cream (containing 10% w/w of glucosamine sulfate)
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Other Names:
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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
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1 to 3 hours post-intervention
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Concentration of glucosamine in synovial fluid
Time Frame: At baseline
|
For the Control group
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At baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
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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