Overview

Esflurbiprofen Hydrogel Patch vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Acute Strains, Sprains or Bruises of the Extremities

Status:
Recruiting

Trial end date:
2022-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Teikoku Seiyaku Co., Ltd.

Collaborators:

Clinigen GmbH
Clinsearch GmbH
CRM Biometrics GmbH

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.