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Phase III Trial to Evaluate the Efficacy and Safety in Patients With Ankle Sprains.

NCT06866613 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2025-11-26

No results posted yet for this study

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.

Conditions

  • Ankle Sprains

Interventions

DRUG

Esflurbiprofen Topical System (EFTS)

One EFTS is applied to the injured area over consecutive 7 days

DRUG

Placebo Patch

One placebo patch is applied to the injured area over consecutive 7 days

Sponsors & Collaborators

  • CRM Biometrics GmbH

    collaborator INDUSTRY

  • SocraTec R&D GmbH

    collaborator OTHER

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • HWI pharma services GmbH

    collaborator INDUSTRY

  • Clinsearch GmbH

    collaborator UNKNOWN

  • Teikoku Seiyaku Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kenichi Nishiyama · Teikoku Seiyaku Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2025-10-18
Completion
2025-10-30
FDA Drug
Yes

Countries

  • Germany

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06866613 on ClinicalTrials.gov