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Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain

NCT04908748 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-09-28

Study results available
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Summary

Objective of this study is:

to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries.

to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the patch has acceptable local tolerability.

Conditions

  • Soft Tissue Injuries
  • Contusions
  • Strains
  • Sprains
  • Bruises

Interventions

DRUG

Esflurbiprofen Hydrogel Patch

Esflurbiprofen is a cyclooxygenase (COX) inhibitor

Sponsors & Collaborators

  • ClinSearch

    collaborator OTHER

  • CRM Biometrics GmbH

    collaborator INDUSTRY

  • Clinigen, Inc.

    collaborator INDUSTRY

  • Teikoku Seiyaku Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hiroshi Aoki · Teikoku Seiyaku Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2021-11-09
Completion
2021-12-15
FDA Drug
Yes

Countries

  • Germany

Study Locations

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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 NCT04908748 on ClinicalTrials.gov