drugset / Trial / NCT06866613
Phase III Trial to Evaluate the Efficacy and Safety in Patients With Ankle Sprains.
Phase 3
Completed
69 enrolled
Teikoku Seiyaku Co., Ltd.
CRM Biometrics GmbH · collabClinSearch · collabHWI pharma services GmbH · collabSocraMetrics GmbH · collabSocraTec R&D GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is a multi-center, double-blind, randomized controlled trial to evaluate the efficacy and safety of EFTS vs. placebo in patients with ankle sprains. The primary objective of this study is to demonstrate that the EFTS is superior in pain reduction compared to a matching placebo in patients with ankle sprains. The secondary objective is to evaluate tolerability, local tolerability, and adhesion of EFTS vs. placebo.
Timeline
- Start
- 2025-03-31
- Primary completion
- 2025-10-18
- Completion
- 2025-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esflurbiprofen | Small molecule | 165 mg | Topical |
Indications
No indication recorded.