MedDataX Logo

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

NCT ID: NCT06351917

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-24

Study Completion Date

2024-06-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Joint Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PlexoZome® Levagen® topical spray solution

Intervention Type DRUG

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

Placebo Comparator

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

Group Type PLACEBO_COMPARATOR

Placebo topical spray solution

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PlexoZome® Levagen® topical spray solution

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

Intervention Type DRUG

Placebo topical spray solution

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RDC Clinical Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amanda Rao, PhD

Role: PRINCIPAL_INVESTIGATOR

RDC Clinical Pty Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RDC Clinical Pty Ltd

Brisbane, Queensland, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LEVEXE

Identifier Type: -

Identifier Source: org_study_id