Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- RDC Clinical Pty Ltd
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Joint pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •( 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)
Arms & Interventions
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.
Intervention: PlexoZome® Levagen® topical spray solution (Drug)
Placebo Comparator
Placebo topical spray solution applied as 3 full pumps on the affected knee area providing 0mg of active per 3 pumps.
Intervention: Placebo topical spray solution (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)