Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 4:15 PM
Study NCT ID:
NCT03380559
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2017-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPITOX
Brief 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.
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.
Detailed Description:
This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis.
All patients will be randomized in 3 following parallel treatment groups:
Group A : botulinum toxin + corticoid
Group C : placebo of toxin + corticoid
Group T : botulinum toxin + placebo corticoid
The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment.
All patients will be randomized in 3 following parallel treatment groups:
Group A : botulinum toxin + corticoid
Group C : placebo of toxin + corticoid
Group T : botulinum toxin + placebo corticoid
The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-001709-33 | EUDRACT_NUMBER | None | View |