Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06351917




Registration number
NCT06351917
Ethics application status
Date submitted
2/04/2024
Date registered
8/04/2024
Date last updated
10/04/2024

Titles & IDs
Public title
Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain
Scientific title
Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain
Secondary ID [1] 0 0
LEVEXE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Joint Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PlexoZome® Levagen® topical spray solution
Treatment: Drugs - Placebo topical spray solution

Experimental: PlexoZome® Levagen® - PlexoZome® 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 - Placebo topical spray solution applied as 3 full pumps on the affected knee area providing 0mg of active per 3 pumps.


Treatment: Drugs: PlexoZome® Levagen® topical spray solution
PlexoZome® Levagen® topical spray solution 10mg/g providing 1.8mg active per pump

Treatment: Drugs: Placebo topical spray solution
Placebo topical spray solution topical spray solution 0mg/g providing 0mg active per pump
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Joint pain
Timepoint [1] 0 0
Up to 5 knee pain treatment events for up to 4 weeks
Secondary outcome [1] 0 0
Time to pain relief
Timepoint [1] 0 0
Up to 5 knee pain treatment events for up to 4 weeks
Secondary outcome [2] 0 0
Number of Adverse Events
Timepoint [2] 0 0
Enrolment period
Secondary outcome [3] 0 0
Severity of Adverse Events
Timepoint [3] 0 0
Enrolment period
Secondary outcome [4] 0 0
Rescue medication use
Timepoint [4] 0 0
Up to 5 knee pain treatment events for up to 4 weeks

Eligibility
Key inclusion criteria
- 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
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06351917
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Rao, PhD
Address 0 0
RDC Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 414 488 559
Fax 0 0
Email 0 0
amanda@rdcglobal.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06351917