Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain
Condition: Soft Tissue Injuries; Contusions; Strains; Sprains; Bruises
MeSH terms: Sprains and Strains; Soft Tissue Injuries; Contusions
Intervention: Esflurbiprofen Hydrogel Patch
Intervention description: Esflurbiprofen is a cyclooxygenase (COX) inhibitor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, double-blind, multi-center
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Blunt Trauma

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.
    

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.