drugset / Trial / NCT03380559
A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 50 iu | — |
| Subject | Hydrocortancyl | Other / unclassified | 2 ml | — |
| Subject | Hydrocortancyl | Other / unclassified | 2.5 % | — |