Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain

Phase 4

Completed

• Conditions: Knee Joint Pain
• Interventions: Drug: PlexoZome® Levagen® topical spray solution; Drug: Placebo topical spray solution

• Registration Number: NCT06351917
• Lead Sponsor: RDC Clinical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-08
• Study Start: 2024-04-24
• Primary Completion: 2024-06-18
• Study Completion: 2024-06-18
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Joint pain	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.

Secondary Outcome Measures

Name	Time	Method
Time to pain relief	Up to 5 knee pain treatment events for up to 4 weeks	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.
Number of Adverse Events	Enrolment period	Number of Adverse Events via AE monitoring
Severity of Adverse Events	Enrolment period	Severity of Adverse Events via AE monitoring
Rescue medication use	Up to 5 knee pain treatment events for up to 4 weeks	Rescue medication use via self-report

Trial Locations

Locations (1)

RDC Clinical Pty Ltd; 🇦🇺 Brisbane, Queensland, Australia