Knee Joint PainPhase 4NCT06351917
Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain
A Phase 4 study testing PlexoZome® Levagen® topical spray solution in people with Knee Joint Pain, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Knee Joint Pain
- What is being tested?
- PlexoZome® Levagen® topical spray solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Apr 2024to 18 Jun 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 20 years
- Generally healthy
- Able to provide informed consent
- Undertaking regular exercise
- Experiencing post exercise knee pain of at least 3 (on a 0-10 scale) at least 2 times in previous 4 weeks
- Agree not to change current diet and/or exercise frequency or intensity
Who cannot join
- Serious illness( 1 ) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
- Unstable illness( 2 ) e.g., diabetes and thyroid gland dysfunction
- Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
- Active smokers, nicotine use, alcohol( 3 ) or drug (prescription or illegal substances) abuse
- Allergic to any of the ingredients in the active or placebo formula
Show all 12Show fewer
- Pregnant or lactating women
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- Footnotes
- ( 1 )A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- ( 2 )An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
- ( 3 )Chronic past and/or current alcohol use (>14 alcohol drinks/week)
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration.
- Conditions
- Knee Joint Pain
- Being tested
- PlexoZome® Levagen® topical spray solution, Placebo topical spray solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlexoZome® Levagen® topical spray solutionDrug
PlexoZome® Levagen® topical spray solution 10mg/g providing 1.8mg active per pump
Placebo topical spray solutionDrug
Placebo topical spray solution topical spray solution 0mg/g providing 0mg active per pump
| Study group | Role | What they receive |
|---|---|---|
| PlexoZome® Levagen® | Experimental | PlexoZome® Levagen® topical spray solution applied as 3 full pumps on the affected knee area providing 5.6mg of active per 3 pumps. Receives: Drug: PlexoZome® Levagen® topical spray solution |
| Placebo Comparator | Placebo comparator | Placebo topical spray solution applied as 3 full pumps on the affected knee area providing 0mg of active per 3 pumps. Receives: Drug: Placebo topical spray solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint pain
Joint pain via Visual Analogue Scale (VAS) Pain Scale which requires a pain rating from 1 to 10 with 1 indicating no pain and 10 indicating worse pain possible.
Measured: Up to 5 knee pain treatment events for up to 4 weeks
Secondary outcomes (4)
Time to pain relief
Time to pain relief via Visual Analogue Scale (VAS) Pain Scale which requires a pain rating from 1 to 10 with 1 indicating no pain and 10 indicating worse pain possible.
Measured: Up to 5 knee pain treatment events for up to 4 weeks
Number of Adverse Events
Number of Adverse Events via AE monitoring
Measured: Enrolment period
Severity of Adverse Events
Severity of Adverse Events via AE monitoring
Measured: Enrolment period
Rescue medication use
Rescue medication use via self-report
Measured: Up to 5 knee pain treatment events for up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start24 Apr 2024
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Joint PainStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda Rao, PhD, Principal investigator, RDC Clinical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351917
- Sponsor's protocol ID
- LEVEXE
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain
- ClinicalTrials.gov ID
- NCT06351917
- Acronym / sponsor ID
- LEVEXE
- Conditions
- Knee Joint Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 8 Apr 2024 (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.
This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PlexoZome® Levagen® | Experimental | Drug: PlexoZome® Levagen® topical spray solutionPlexoZome® Levagen® topical spray solution applied as 3 full pumps on the affected knee area providing 5.6mg of active per 3 pumps. |
| Placebo Comparator | Placebo comparator | Drug: Placebo topical spray solutionPlacebo topical spray solution applied as 3 full pumps on the affected knee area providing 0mg of active per 3 pumps. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults over 20 years
- Generally healthy
- Able to provide informed consent
- Undertaking regular exercise
- Experiencing post exercise knee pain of at least 3 (on a 0-10 scale) at least 2 times in previous 4 weeks
Key exclusion criteria (12 listed)
- Serious illness( 1 ) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
- Unstable illness( 2 ) e.g., diabetes and thyroid gland dysfunction
- Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
- Active smokers, nicotine use, alcohol( 3 ) or drug (prescription or illegal substances) abuse
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 |
|---|---|---|
| PlexoZome® Levagen® topical spray solutionPlexoZome® Levagen® topical spray solution 10mg/g providing 1.8mg active per pump | Drug | PlexoZome® Levagen® |
| Placebo topical spray solutionPlacebo topical spray solution topical spray solution 0mg/g providing 0mg active per pump | Drug | Placebo Comparator |
Primary outcome
Joint pain
Time frame: Up to 5 knee pain treatment events for up to 4 weeks
Joint pain via Visual Analogue Scale (VAS) Pain Scale which requires a pain rating from 1 to 10 with 1 indicating no pain and 10 indicating worse pain possible.
4 secondary outcomes
Time to pain relief
Time frame: Up to 5 knee pain treatment events for up to 4 weeks
Number of Adverse Events
Time frame: Enrolment period
Severity of Adverse Events
Time frame: Enrolment period
Rescue medication use
Time frame: Up to 5 knee pain treatment events for up to 4 weeks
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 5 Dec 2024.
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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.
Amanda Rao, PhD principal investigator
RDC Clinical Pty Ltd
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 PlexoZome® Levagen® topical spray solution in people with Knee Joint Pain, run by RDC Clinical Pty Ltd at 1 site in Australia.
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 6 inclusion and 12 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 5 Dec 2024. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Joint pain (time frame: Up to 5 knee pain treatment events for up to 4 weeks). 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 5 Dec 2024.