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Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

The Efficacy and Safety of an Esflurbiprofen Hydrogel Patch vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Acute Strains, Sprains or Bruises of the Extremities Following Blunt Trauma, e.g. Sports Injuries.

NCT04908748•Teikoku Seiyaku Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed Description

Study Design Randomized (1:1) (stratified by center and 2 subgroups), controlled, double-blind, multi-centric study in parallel groups. Patient Population/Sample size/Study Sites The clinical trial population will consist of male or female patients, 18 - 60 years suffering from acute; strains, sprains or bruises of the extremities following blunt trauma, and meeting all clinical trial entry criteria. 200 patients will be enrolled (assumes a drop-out-rate of ≤10%). The study will be performed in Germany in 3 sites

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb
•2. location of injury such that pain-on-movement (POM) is elicited on by specified exercises
•3. enrollment within 6 hours of the injury
•4. baseline VAS score for POM of injured extremity \> 50 mm on a 100 mm VAS
•5. size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2
•6. adult male or female patients
•7. age 18 to 60 years
•8. having given written informed consent
•9. satisfactory health as determined by the Investigator based on medical history and physical examination.

Exclusion Criteria

•1. significant concomitant injury in association with the index acute sports-related soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
•2. excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
•3. current skin disorder or shaving hair at application site
•4. history of excessive sweating/hyperhidrosis inclusive of application site
•5. intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study
•6. intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
•7. participation in a clinical study within 30 days before inclusion in the study or concomitantly
•8. drug or alcohol abuse in the opinion of the investigator
•9. Pregnant and lactating women
•10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
+5 more criteria

Locations (1)

Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin

Cologne, North Rhine-Westphalia, Germany

Key Dates

Start Date

May 20, 2021

Primary Completion Date

November 9, 2021

Completion Date

December 15, 2021

Last Updated

September 28, 2023

Enrollment

200

ACTUAL participants

Conditions

Soft Tissue InjuriesContusionsStrainsSprainsBruises

Interventions

Esflurbiprofen Hydrogel Patch

DRUG

Dermal Wound Closure Using Silkam®

NCT05225714

ContusionsIncision+1 more

View study

ENROLLING_BY_INVITATIONPHASE2

Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

NCT03544632

Soft Tissue InjuriesTrauma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Dermal Wound Closure Using Silkam®

Acellular Adipose Tissue (AAT) for Soft Tissue Reconstruction

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