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

Primary Purpose

Soft Tissue Injuries, Contusions, Strains

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Esflurbiprofen Hydrogel Patch

About this trial

This is an interventional treatment trial for Soft Tissue Injuries focused on measuring Blunt Trauma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Arm

Control Drug

Arm Description

Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen

Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch

Outcomes

Primary Outcome Measures

Change of Pain-on-movement (POM) Compared to Baseline

Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"

Secondary Outcome Measures

Pain-on-movement (POM) on VAS

Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"

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"

Pain-at-rest on VAS

Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"

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"

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"

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"

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]

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]

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]

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).

Resolution of Soft Tissue Injury/Contusion

Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (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.

Responder Rate 2 at 168h

defined as the percentage of patients able to resume training/normal physical activity by 168 hours

Full Information

NCT ID

NCT04908748

First Posted

May 21, 2021

Last Updated

September 27, 2023

Sponsor

Teikoku Seiyaku Co., Ltd.

Collaborators

ClinSearch, CRM Biometrics GmbH, Clinigen, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04908748

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

May 20, 2021 (Actual)

Primary Completion Date

November 9, 2021 (Actual)

Study Completion Date

December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teikoku Seiyaku Co., Ltd.

Collaborators

ClinSearch, CRM Biometrics GmbH, Clinigen, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Injuries, Contusions, Strains, Sprains, Bruises

Keywords

Blunt Trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized, controlled, double-blind, multi-center

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Packages of Investigative Medicinal product will be non-distinguishable to patients, study site staff and monitors. Randomization data are kept strictly confidential, accessible only to authorized persons, until the time of unblinding the identity of the treatments will be concealed by the use of study drugs that are all identical in packaging, labeling, schedule of administration, appearance and odor. Unblinding will only occur in the case of patient emergencies and at the conclusion of the study.

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Arm

Arm Type

Experimental

Arm Description

Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen

Arm Title

Control Drug

Arm Type

Placebo Comparator

Arm Description

Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch

Intervention Type

Drug

Intervention Name(s)

Esflurbiprofen Hydrogel Patch

Intervention Description

Esflurbiprofen is a cyclooxygenase (COX) inhibitor

Primary Outcome Measure Information:

Title

Change of Pain-on-movement (POM) Compared to Baseline

Description

Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"

Time Frame

Change from baseline to Visit 5 (72 hours after initiating treatment)

Secondary Outcome Measure Information:

Title

Pain-on-movement (POM) on VAS

Description

Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"

Time Frame

Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment

Title

Area-under-the-curve for POM on VAS

Description

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"

Time Frame

Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment

Title

Pain-at-rest on VAS

Description

Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"

Time Frame

Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment

Title

Time to Meaningful and Optimal Reduction

Description

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 Frame

Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment

Title

Time to Complete Resolution of Pain

Description

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"

Time Frame

Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment

Title

Responder Rate 1

Description

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"

Time Frame

72 hours

Title

Global Efficacy Assessments 1 by Patient

Description

Time Frame

48 h, 72 h, and 168 h

Title

Global Efficacy Assessments 2 by Patient

Description

Time Frame

48 h, 72 h, and 168 h

Title

Global Efficacy Assessments 1 by Investigator

Description

Time Frame

48 h, 72 h, and 168 h

Title

Use of Rescue Medication

Description

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).

Time Frame

0-168h

Title

Resolution of Soft Tissue Injury/Contusion

Description

Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h).

Time Frame

168h

Title

SPID of POM VAS Changes

Description

Time Frame

0-24 h, 0-48 h, 0-72 h, and 0-96 h

Title

Responder Rate 2 at 168h

Description

defined as the percentage of patients able to resume training/normal physical activity by 168 hours

Time Frame

168h

Other Pre-specified Outcome Measures:

Title

Adhesive Power of the Patch

Description

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.

Time Frame

12h for day 1, 24h for day 1-5 and 7 after application of each patch

Title

Local Tolerability

Description

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

Time Frame

24, 48, 72, 96, 168h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroshi Aoki

Organizational Affiliation

Teikoku Seiyaku Co., Ltd.

Official's Role

Study Chair

Facility Information:

Facility Name

Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin

City

Cologne

State/Province

NRW

ZIP/Postal Code

50933

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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