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Completed

NCT Number: NCT04908748

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

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.

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Key information

Conditions

Soft Tissue Injuries Bruises Contusions Sprains Sprains and Strains Strains Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin

Cologne, North Rhine-Westphalia, 50933, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esflurbiprofen Hydrogel Patch

Drug

Esflurbiprofen is a cyclooxygenase (COX) inhibitor

Primary outcomes

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

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

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

Secondary outcomes

  1. Pain-on-movement (POM) on VAS

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

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

  2. Area-under-the-curve for POM on VAS

    Time frame: 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"

  3. Pain-at-rest on VAS

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

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

  4. Time to Meaningful and Optimal Reduction

    Time frame: 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"

  5. Time to Complete Resolution of Pain

    Time frame: 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"

  6. Responder Rate 1

    Time frame: 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"

  7. Global Efficacy Assessments 1 by Patient

    Time frame: 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]

  8. Global Efficacy Assessments 2 by Patient

    Time frame: 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]

  9. Global Efficacy Assessments 1 by Investigator

    Time frame: 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]

  10. Use of Rescue Medication

    Time frame: 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).

  11. Resolution of Soft Tissue Injury/Contusion

    Time frame: 168h

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

  12. SPID of POM VAS Changes

    Time frame: 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.

  13. Responder Rate 2 at 168h

    Time frame: 168h

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

Other outcomes

  1. Adhesive Power of the Patch

    Time frame: 12h for day 1, 24h for day 1-5 and 7 after application of each 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.

  2. Local Tolerability

    Time frame: 24, 48, 72, 96, 168h

    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

Sponsors and collaborators

Lead sponsor

Teikoku Seiyaku Co., Ltd.

Industry

Collaborators

  • CRM Biometrics GmbH
  • ClinSearch
  • Clinigen, Inc.

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2021
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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