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

Soft Tissue Injuries Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908748
• Other study ID #: TK-254R-0201
• Status: Completed
• Phase: Phase 2
• Start date: May 20, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: September 2023
• Source: Teikoku Seiyaku Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 15, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

• Surgical sterilization

• Hormonal contraception

• Intra Uterine Device

• Double barrier method

• Total abstinence throughout the study at the discretion of the Investigator.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Esflurbiprofen Hydrogel Patch
Esflurbiprofen is a cyclooxygenase (COX) inhibitor

Locations

Country	Name	City	State
Germany	Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin	Cologne	NRW

Sponsors (4)

Lead Sponsor	Collaborator
Teikoku Seiyaku Co., Ltd.	Clinigen, Inc., ClinSearch, CRM Biometrics GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adhesive Power of the Patch	Adhesive power of the patch measured by a 5 point numerical scale (0= = 90 % adhered, 1= = 75 % to < 90 % adhered, 2= = 50 % to < 75 % adhered, 3= > 0 % to <50 % adhered, 4=completely detached) at every visit except V1.	12h for day 1, 24h for day 1-5 and 7 after application of each patch
Other	Local Tolerability	Local tolerability was assessed by the Investigator according to the following numerical scale: 0: No evidence of irritation; Minimal erythema, barely perceptible; Definite erythema, readily visible, minimal edema or minimal papular response; Erythema and papules; Definite edema; Erythema, edema and papules; Vesicular eruption; Strong reaction spreading beyond test site	24, 48, 72, 96, 168h
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Resolution of Soft Tissue Injury/Contusion	Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h).	168h
Secondary	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
Secondary	Responder Rate 2 at 168h	defined as the percentage of patients able to resume training/normal physical activity by 168 hours	168h