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

RDC Clinical

Status and phase: Completed; Phase 4

Conditions: Knee Joint Pain

Treatments: Drug: PlexoZome® Levagen® topical spray solution; Drug: Placebo topical spray solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT06351917

LEVEXE

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

PlexoZome® Levagen®

Experimental group

Description:

PlexoZome® Levagen® topical spray solution applied as 3 full pumps on the affected knee area providing 5.6mg of active per 3 pumps.

Treatment:

Drug: PlexoZome® Levagen® topical spray solution

Placebo Comparator

Placebo Comparator group

Description:

Placebo topical spray solution applied as 3 full pumps on the affected knee area providing 0mg of active per 3 pumps.

Treatment:

Drug: Placebo topical spray solution