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

Teikoku Seiyaku

Status and phase

Completed

Phase 3

Conditions

Contusions

Treatments

Drug: Esflurbiprofen Topical System (EFTS)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06871046

TK-254RX-0302

2024-513064-26-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment

221 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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