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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PlexoZome® Levagen® topical spray solution | Drug | PlexoZome® Levagen® topical spray solution 10mg/g providing 1.8mg active per pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to pain relief | 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. | Up to 5 knee pain treatment events for up to 4 weeks |
| Number of Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Rao, PhD | RDC Clinical Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical Pty Ltd | Brisbane | Queensland | 4006 | Australia |
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| Placebo topical spray solution | Drug | Placebo topical spray solution topical spray solution 0mg/g providing 0mg active per pump |
|
Number of Adverse Events via AE monitoring |
| Enrolment period |
| Severity of Adverse Events | Severity of Adverse Events via AE monitoring | Enrolment period |
| Rescue medication use | Rescue medication use via self-report | Up to 5 knee pain treatment events for up to 4 weeks |