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

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Soft Tissue Injuries, Contusions, Strains, Sprains, Bruises

Intervention / Treatment
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* Drug: Esflurbiprofen Hydrogel Patch


Participation Criteria
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Eligibility Criteria
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Inclusion criteria acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb location of injury such that pain-on-movement (POM) is elicited on by specified exercises enrollment within 6 hours of the injury baseline VAS score for POM of injured extremity > 50 mm on a 100 mm VAS size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2 adult male or female patients age 18 to 60 years having given written informed consent satisfactory health as determined by the Investigator based on medical history and physical examination. Exclusion criteria 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 excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion current skin disorder or shaving hair at application site history of excessive sweating/hyperhidrosis inclusive of application site intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed) participation in a clinical study within 30 days before inclusion in the study or concomitantly drug or alcohol abuse in the opinion of the investigator Pregnant and lactating women 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: Surgical sterilization Hormonal contraception Intra Uterine Device Double barrier method Total abstinence throughout the study at the discretion of the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, double-blind, multi-center
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Arm<br>Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen | Drug: Esflurbiprofen Hydrogel Patch<br>* Esflurbiprofen is a cyclooxygenase (COX) inhibitor<br>|
| Placebo Comparator: Control Drug<br>Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch | Drug: Esflurbiprofen Hydrogel Patch<br>* Esflurbiprofen is a cyclooxygenase (COX) inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain-on-movement (POM) Compared to Baseline | Visual Analogue Scale (VAS) 0 = no pain, 100 = Extreme pain | Change from baseline to Visit 5 (72 hours after initiating treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-on-movement (POM) on VAS | Visual Analogue Scale (VAS) 0 = no pain, 100 = Extreme pain | Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment | 
| Area-under-the-curve for POM on VAS | Area-under-the-curve (AUC) over time during first 12, 24, 48, 72, 96 and 168 hours for Pain on movement (POM) measured using a VAS Visual Analogue Scale (VAS) 0 = no pain, 100 = Extreme pain | Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment | 
| Pain-at-rest on VAS | Visual Analogue Scale (VAS) 0 = no pain, 100 = Extreme pain | Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment | 
| Time to Meaningful and Optimal Reduction | The time taken to achieve a meaningful (30 %) and optimal (50 %) reduction of pain measured on the VAS for POM Visual Analogue Scale (VAS) 0 = no pain, 100 = Extreme pain | Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment | 
| Time to Complete Resolution of Pain | Time to complete resolution of pain, i. e. reaching a POM VAS value of 0 mm after start of study treatment Visual Analogue Scale (VAS) 0 = no pain, 100 = Extreme pain | Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment | 
| Responder Rate 1 | defined as the percentage of patients achieving ≥50% reduction from baseline in the VAS score for POM at 72 hours Visual Analogue Scale (VAS) 0 = no pain, 100 = Extreme pain | 72 hours | 
| Global Efficacy Assessments 1 by Patient | The global efficacy was assessed by the patients. The patients answered question below; -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). [Global efficacy assessment 1] | 48 h, 72 h, and 168 h | 
| Global Efficacy Assessments 2 by Patient | The global efficacy was assessed by the patients. The patients answered question below -How do you rate this medication as treatment for your soft injury/contusion? (5-point Likert scale: 0 = excellent, 1 = very good, 2 = good, 3 = fair, and 4 = poor). [Global efficacy assessment 2] | 48 h, 72 h, and 168 h | 
| Global Efficacy Assessments 1 by Investigator | The global efficacy was assessed by the investigator. -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). [Global efficacy assessment 1] | 48 h, 72 h, and 168 h | 
| Use of Rescue Medication | Rescue medication (paracetamol, 500 mg tablets, up to 3000 mg daily) was allowed during the study, except for the 6 hours prior to V5 (72 h). | 0-168h | 
| Resolution of Soft Tissue Injury/Contusion | Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h). | 168h | 
| SPID of POM VAS Changes | The sum of pain intensity difference (SPID) of POM on VAS changes over 0-24 h, 0-48 h, 0-72 h, and 0-96 h were calculated. SPID was calculated as the area under the curve of the VAS difference from baseline value. | 0-24 h, 0-48 h, 0-72 h, and 0-96 h | 
| Responder Rate 2 at 168h | defined as the percentage of patients able to resume training/normal physical activity by 168 hours | 168h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blunt Trauma