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

Phase 2

Completed

Conditions: Soft Tissue Injuries
Contusions
Strains
Sprains
Bruises

Interventions: Drug: Esflurbiprofen Hydrogel Patch

Registration Number: NCT04908748

Lead Sponsor: Teikoku Seiyaku Co., Ltd.

Brief 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Arm	Esflurbiprofen Hydrogel Patch	Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
Control Drug	Esflurbiprofen Hydrogel Patch	Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain-on-movement (POM) on VAS	Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment	Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Area-under-the-curve for POM on VAS	Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment	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"
Pain-at-rest on VAS	Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment	Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Time to Meaningful and Optimal Reduction	Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment	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"
Time to Complete Resolution of Pain	Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment	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"
Responder Rate 1	72 hours	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"
Resolution of Soft Tissue Injury/Contusion	168h	Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h).
SPID of POM VAS Changes	0-24 h, 0-48 h, 0-72 h, and 0-96 h	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.
Responder Rate 2 at 168h	168h	defined as the percentage of patients able to resume training/normal physical activity by 168 hours
Global Efficacy Assessments 1 by Patient	48 h, 72 h, and 168 h	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). \[Global efficacy assessment 1\]
Global Efficacy Assessments 1 by Investigator	48 h, 72 h, and 168 h	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). \[Global efficacy assessment 1\]
Global Efficacy Assessments 2 by Patient	48 h, 72 h, and 168 h	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). \[Global efficacy assessment 2\]
Use of Rescue Medication	0-168h	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).