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Completed

NCT Number: NCT06351917

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.

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Key information

Conditions

Knee Joint Pain

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PlexoZome® Levagen® topical spray solution

Drug

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

Placebo topical spray solution

Drug

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

Primary outcomes

  1. 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

  1. Time to pain relief

    Time frame: Up to 5 knee pain treatment events for up to 4 weeks

    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.

  2. Number of Adverse Events

    Time frame: Enrolment period

    Number of Adverse Events via AE monitoring

  3. Severity of Adverse Events

    Time frame: Enrolment period

    Severity of Adverse Events via AE monitoring

  4. Rescue medication use

    Time frame: Up to 5 knee pain treatment events for up to 4 weeks

    Rescue medication use via self-report

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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