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

Teikoku Seiyaku

Status and phase: Completed; Phase 2

Conditions: Contusions; Soft Tissue Injuries; Sprains; Bruises; Strains

Treatments: Drug: Esflurbiprofen Hydrogel Patch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04908748

TK-254R-0201

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Active Arm

Experimental group

Description:

Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen

Treatment:

Drug: Esflurbiprofen Hydrogel Patch

Control Drug

Placebo Comparator group

Description:

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

Treatment:

Drug: Esflurbiprofen Hydrogel Patch