drugset / Trial / NCT03380559

A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis

NCT03380559

Phase 3 Completed 33 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months. As secondary objectives, the study aims to * demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities. * evaluate tolerance of treatment by grip strength measurement and adverse event collection.

Timeline

Start
2019-04-19
Primary completion
2021-07-07
Completion
2021-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu
Subject Hydrocortancyl Other / unclassified 2 ml
Subject Hydrocortancyl Other / unclassified 2.5 %

Indications