EUCTR2014-001720-30-DE进行中（未招募）1 期
A randomized, double-blind, multi-center, placebo-controlled, parallel group study to evaluate the efficacy and safety of an etofenamate 5% (EFM) cutaneous patch applied twice daily in patients with acute uncomplicated unilateral ankle sprain for a period of 7 consecutive days.Abbreviated title: Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of an etofenamate 5% cutaneous patch vs. placebo in the treatment of acute uncomplicated unilateral ankle sprain - Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of an e
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1. Acute uncomplicated unilateral ankle sprain, Grade I or II
- •2. Enrolment within 12 hours of the injury
- •3. Baseline VAS score for (investigator manipulated) pain on movement (POM) of injured ankle = 50 mm on a 100 mm VAS
- •4. Adult male or female patients
- •5. Age 18 to 60 years
- •6. Having given written informed consent
- •7. Satisfactory health as determined by the Investigator based on medical history and physical examination.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key exclusion criteria:
- •Patients eligible for inclusion in this clinical trial must not fulfill any of the following criteria:
- •1. Serious injury in the area of the foot or ankle, including 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. Participation in a clinical clinical trial within 30 days before entry or concomitantly
- •8. Drug or alcohol abuse in the opinion of the investigator
- •9. Pregnant and lactating women
- •10. Women of child-bearing potential without medically accepted contraception
- •11. Known hypersensitivity to etofenamate or one of the excipients of the patch
- •12. History of previous grade I ankle sprain (same ankle) within 6 months, or previous grade II sprain, or other significant injury to the same ankle or foot within 6 months.
- •13. Patients with history of previous grade III ankle sprain (same ankle).
- •14. Patients with a disease affecting the same ankle, such as synovitis, rheumatoid arthritis, arthrosis, etc.
- •15. Patients suffering from symptoms of an infectious disease including swelling of any joint of the affected lower limb
- •16. Patients who had surgery of the affected lower limb within one year of clinical trial entry
- •17. 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 clinical trial or a disease which may influence the results of the clinical trial or the patient’s ability to participate in the clinical trial; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease).
- •18. Patients with a blood coagulation disorder
- •19. Patients who use any impermissible medication
研究者
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