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

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 Overview

• Status: Completed
• Conditions: Knee Joint Pain
• Intervention / Treatment: Drug: PlexoZome® Levagen® topical spray solution; Drug: Placebo topical spray solution

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • RDC Clinical Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: PlexoZome® Levagen® topical spray solution; PlexoZome® Levagen® topical spray solution 10mg/g providing 1.8mg active per pump
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.	Drug: Placebo topical spray solution; Placebo topical spray solution topical spray solution 0mg/g providing 0mg active per pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 knee pain treatment events for up to 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Investigators: Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2024
• Primary Completion (Actual): June 18, 2024
• Study Completion (Actual): June 18, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia; Pharmaceutical Solutions
• Other Study ID Numbers: LEVEXE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No