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

NCT06351917 | Completed Phase 4

• 1 other identifier: LEVEXE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Joint Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to pain relief

  Up to 5 knee pain treatment events for up to 4 weeks

• Number of Adverse Events

  Enrolment period

• Severity of Adverse Events

  Enrolment period

• Rescue medication use

  Up to 5 knee pain treatment events for up to 4 weeks

Study Arms (2)

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.

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.

Drug: Placebo topical spray solution

Interventions

PlexoZome® Levagen® topical spray solution DRUG

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

PlexoZome® Levagen®

Placebo topical spray solution DRUG

Placebo topical spray solution topical spray solution 0mg/g providing 0mg active per pump

Placebo Comparator

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

Study Officials

• Amanda Rao, PhD

  RDC Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 24, 2024
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-04

Locations

AU (1)