Acute strains, sprains or bruises of soft tissues following blunt trauma, e.g. sports injuries
Conditions
Interventions
Trade Name: Lixim 70 mg wirkstoffhaltiges Pflaster
Product Name: Etofenamat
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Lixim 70 mg wirkstoffhaltiges Pflaster
Other descriptive name: E
Sponsors
Drossapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this clinical trial must fulfill all of the following criteria: 1. acute sports-related soft-tissue injury/contusion 2. location of injury such that pain on movement (POM) is elicited on passive manipulation of nearest joint by the investigator 3. enrolment within 6 hours of the injury 4. baseline VAS score for (investigator manipulated) POM of injured limb = 50 mm on a 100 mm VAS 5. size of injury, as assessed by investigator, = 25 cm2 and = 120 cm2 6. adult and adolescent male and female patients aged =16 years 7. having given written informed consent (patients =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients eligible for inclusion in this clinical trial must not fulfill any of the following 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. 3. Chronic skin disorder at application site. 4. History of excessive sweating inclusive of application site. 5. Intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of clinical trial start. 6. Intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed). 7. Previous participation in this clinical trial or participation in a clinical trial within 30 days before entry or concomitantly. 8. Drug or alcohol abuse in the opinion of the investigator 9. Pregnant or nursing (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 11. History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: etofenamate, acetaminophen (paracetamol) or known intolerance (cutaneous or systemic) to any of the ingredients in the plaster, such as silicone adhesive, PEG 400 and olive oil. 12. Patients with any ongoing conditions that may interfere with the absorption, distribution, metabolism or excretion of etofenamate 13. History of previous significant injury to the same limb within 6 months 14. Patients with a disease affecting the same limb, such as synovitis, rheumatoid arthritis, arthrosis, etc. 15. Patients having an ongoing painful condition associated with sports-related injury/contusion 16. Patients suffering from symptoms of an infectious disease including swelling of any joint of the affected upper or lower limbs 17. Patients who had surgery of the affected upper or lower limb within one year of study entry 18. Any physical impairment that would influence the clinical trials efficacy evaluations, in particular POM and the ankle joint function, such as: peripheral or central neurological disease, significant back pain, symptomatic osteoarthritis of the hips, knees, or feet, or any painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart). 19. Intent to undergo surgery during time of clinical trial participation. 20. Any skin lesion or wound or infection in the area to be treated. 21. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated. 22. Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), or a significant coagulation defect, patients reported only. 23. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening. 24. History of clinically significant cardiovascular, cerebrovascular, metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders, including individuals with Type I or Type II diabetes, all patient reported. 25. History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate clinical trial participation or confound interpretation of the results. 26. Uncontrolled psychiatric disease or history of known narcotic, analge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the Test plaster is superior to placebo with regards to pain relief;Secondary Objective: To demonstrate that the Test plaster has acceptable local tolerability. Adhesion power of the plaster;Primary end point(s): Primary efficacy outcome is change from baseline of pain on movement at 72 hours after initiating treatment.;Timepoint(s) of evaluation of this end point: At Visit 5 (72 hours after initiating study treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • POM on VAS at Visits 2, 3, 4, 6 and 7 (12, 24, 48, 96 and 120 hours after initiating treatment). • POM on VAS at Visit 7 (Day 8 (±1); 168 hours). • Pain at Rest at Visit 5 (72 hours after beginning of treatment) • AUC of POM VAS pain scores over the 0-24, 0-48, 0-72, 0-96 and 0-120 hours • Pain Intensity Difference (PID) and (SPID) Sum of Pain Intensity Difference at the respective time points for POM and AUC of POM • Global efficacy assessments at Visits 4, 5 and 7 (48 hours, 72 hours and 120 hours after initiating treatment) and Day 8 (±1)) Additional outcomes • Use of rescue medication ;Timepoint(s) of evaluation of this end point: (12, 24, 48, 96, 120 and 168 hours after initiating treatment) | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Giannetti
Clinsearch GmbH
Outcome results
None listed