Osteoarthritis, KneePhase 4NCT03743896
Transdermal Delivery of Glucosamine to the Synovial Fluid of Male and Female With Knee Osteoarthritis
A Phase 4 study testing Transdermal Glucosamine Cream in people with Osteoarthritis, Knee, run by Lynk Biotechnologies Pte Ltd at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Transdermal Glucosamine Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSingapore
- Study dates
- 18 May 2016to 10 Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Transdermal Glucosamine Cream
- Keywords
- Transdermal Delivery, Glucosamine, Synovial Fluid, Osteoarthritis, Knee, Human, Arthrocentesis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Glucosamine CreamDrug
Also called TGC® Plus Capsaicin
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Transdermal Glucosamine Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of glucosamine in synovial fluid
For the Test group
Measured: 1 to 3 hours post-intervention
Concentration of glucosamine in synovial fluid
For the Control group
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start18 May 2016
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynk Biotechnologies Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- T&T Family Health Clinic and Surgery, Singapore, Temasek Polytechnic School of Applied Science, Singapore
- Responsible party
- Sponsor
- Investigators
- Choon Meng Ting, MD, Principal investigator, T&T Family Health Clinic and Surgery, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743896
- Sponsor's protocol ID
- ASC/CPROJ/14/15/16
- Other IDs
- CTC1600169
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03743896
- Acronym / sponsor ID
- ASC/CPROJ/14/15/16
- Conditions
- Osteoarthritis, Knee
- Keywords
- Transdermal Delivery, Glucosamine, Synovial Fluid, Osteoarthritis, Knee, Human, Arthrocentesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Lynk Biotechnologies Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- T&T Family Health Clinic and Surgery, Singapore, Temasek Polytechnic School of Applied Science, Singapore
- Study start
- 18 May 2016 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention |
| Test group | Experimental | Drug: Transdermal Glucosamine Creamsingle dose (2g), topical application of Transdermal Glucosamine Cream (containing 10% w/w of glucosamine sulfate) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal Glucosamine CreamAlso: TGC® Plus Capsaicin | Drug | Test group |
Primary outcome
Concentration of glucosamine in synovial fluid
Time frame: 1 to 3 hours post-intervention
For the Test group
Concentration of glucosamine in synovial fluid
Time frame: At baseline
For the Control group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choon Meng Ting, MD principal investigator
T&T Family Health Clinic and Surgery, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transdermal Glucosamine Cream in people with Osteoarthritis, Knee, run by Lynk Biotechnologies Pte Ltd at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of glucosamine in synovial fluid (time frame: 1 to 3 hours post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.