Clinical trial NCT04908748: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Soft Tissue Injuries
Contusions
Strains
Sprains
Bruises
Keywords: Blunt Trauma
Lead sponsor: Teikoku Seiyaku Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: ClinSearch
name: CRM Biometrics GmbH
name: Clinigen, Inc.
First posted: 2021-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, double-blind, multi-center
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Pain-on-movement (POM) Compared to Baseline
timeFrame: Change from baseline to Visit 5 (72 hours after initiating treatment)
Secondary outcomes:
measure: Pain-on-movement (POM) on VAS
timeFrame: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment
measure: Area-under-the-curve for POM on VAS
timeFrame: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment
measure: Pain-at-rest on VAS
timeFrame: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment
measure: Time to Meaningful and Optimal Reduction
timeFrame: Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment
measure: Time to Complete Resolution of Pain
timeFrame: Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment
measure: Responder Rate 1
timeFrame: 72 hours
measure: Global Efficacy Assessments 1 by Patient
timeFrame: 48 h, 72 h, and 168 h
measure: Global Efficacy Assessments 2 by Patient
timeFrame: 48 h, 72 h, and 168 h
measure: Global Efficacy Assessments 1 by Investigator
timeFrame: 48 h, 72 h, and 168 h
measure: Use of Rescue Medication
timeFrame: 0-168h
measure: Resolution of Soft Tissue Injury/Contusion
timeFrame: 168h
measure: SPID of POM VAS Changes
timeFrame: 0-24 h, 0-48 h, 0-72 h, and 0-96 h
measure: Responder Rate 2 at 168h
timeFrame: 168h
Other outcomes:
measure: Adhesive Power of the Patch
timeFrame: 12h for day 1, 24h for day 1-5 and 7 after application of each patch
measure: Local Tolerability
timeFrame: 24, 48, 72, 96, 168h
Locations:
city: Cologne
country: Germany
facility: Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin
state: NRW
Study officials:
affiliation: Teikoku Seiyaku Co., Ltd.
name: Hiroshi Aoki
role: STUDY_CHAIR
References: