Phase III Trial to Assess the Safety and Efficacy of TK-254RX in Patients With Contusions

An Open-label, Multi-centric Trial to Assess the Safety and Efficacy of an Esflurbiprofen Topical System (EFTS) in the Local Symptomatic and Short-term Treatment of Pain in Contusions.

This study is an open-label, multi-centric clinical trial to evaluate the safety and efficacy of TK-254RX in patients with contusions. The primary objective of this study is to assess the safety of TK-254RX. Secondly objective is to evaluate the efficacy of contusions and adhesion of TK-254RX.

Inclusion Criteria:

• acute contusion of the upper or lower limbs
• location of injury such that pain-on-movement is elicited on active standardized movement
• 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 64 years (including)
• 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 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 (except inhaled corticosteroids for e.g. topical treatment of bronchial asthma) within 60 days of inclusion in the study

• intake of long-acting NSAIDs or application of topical medication since the injury

• participation in a clinical study within 30 days before inclusion in the study or concomitantly

• participation in this clinical study in another center

• 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
  • Combined (estrogen and progestogen containing) hormonal contraception, e.g., oral, intravaginal, transdermal and progestogen-only hormonal contraception e.g. oral, injectable, implantable as well as intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) each in combination with male condom to increase safety effect (double barrier method)
  • Total abstinence throughout the study at the discretion of the Investigator.
  • Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
  • A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of sterilisation, salpingectomy) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.

• known hypersensitivity to Esflurbiprofen, R-flurbiprofen or one of the excipients of the patch

• patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of Esflurbiprofen

• history of previous significant injury to the same area within 6 months

• patients with a disease affecting the same area such as synovitis, rheumatoid arthritis, arthrosis, etc.

• patients having an ongoing painful condition associated with blunt injury/contusion

• patients suffering from symptoms of an infectious disease including swelling of any joint of the affected area

• patients who had surgery of the affected area within one year of study entry

• patients with significant diseases (defined as a disease which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease)

• patients with a blood coagulation disorder

• patients who use any impermissible medication

• known allergy to paracetamol and galenic components of the rescue medication