EUCTR2021-003778-30-DE进行中（未招募）1 期
Randomized, controlled, multi-center trial to evaluate the efficacy and safety of Lixim 70 mg wirkstoffhaltiges Pflaster (etofenamate 70 mg medicated plaster) vs. placebo in the local symptomatic and short-term treatment of pain in acute strains, sprains or bruises of soft tissues following blunt trauma, e.g. sports injuries
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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 < 18 years to provide written assent;
- •their legal representatives to provide written informed consent)
- •8. satisfactory health as determined by the Investigator based on medical history and physical examination
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 162
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
- •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
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