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Phase III Trial to Assess the Safety and Efficacy of TK-254RX in Patients With Contusions

NCT06871046 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2025-10-24

No results posted yet for this study

Summary

This study is an open-label, multi-centric clinical trial to evaluate the safety and efficacy of TK-254RX in patients with contusions. The primary objective of this study is to assess the safety of TK-254RX. Secondly objective is to evaluate the efficacy of contusions and adhesion of TK-254RX.

Conditions

  • Contusions

Interventions

DRUG

Esflurbiprofen Topical System (EFTS)

One EFTS is applied to the injured area over 7 days

Sponsors & Collaborators

  • Clinsearch GmbH

    collaborator UNKNOWN

  • CRM Biometrics GmbH

    collaborator INDUSTRY

  • SocraTec R&D GmbH

    collaborator OTHER

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • HWI pharma services GmbH

    collaborator INDUSTRY

  • Teikoku Seiyaku Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kenichi Nishiyama · Teikoku Seiyaku Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2025-09-22
Completion
2025-10-01
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 NCT06871046 on ClinicalTrials.gov