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EP-104IAR · STEPUP

Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis

Ensayo de EUPRAXIA PHARMACEUTICALS INC. en Artrosis de rodilla.

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Fase

Fase 1

Estado

Completado

Participantes

32

previstos

Centros

3

Fin del objetivo primario

dic 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en abr 2016.

Qué mide

Peak Plasma Concentration (Cmax) of fluticasone propionate (del registro, en inglés) (hasta 42 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The study will also provide some preliminary insights into whether the experimental treatment reduces pain in the knee. Osteoarthritis is the most common joint disease, affecting over 20 million people in the US alone. Currently, pain treatments that are injected directly into the knee often work for only a short time and may also have side effects within the rest of the body. The experimental treatment is a steroid that is in the same family of drugs as the most common current injectable treatments for knee osteoarthritis. For this study, the drug is coated with a polymer intended to prolong the time it stays inside the knee and lessen potential side effects.

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Ficha completa en ClinicalTrials.gov (NCT02609126), actualizada en ago 2021.