EUCTR2019-001038-32-DE进行中（未招募）1 期
Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a Loxoprofen sodium 60 mg tape medicated plaster vs. placebo in the local symptomatic and short-term treatment of pain in acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries
ead Chemical Company Ltd0 个研究点目标入组 132 人开始时间: 2019年7月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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 sports-related soft-tissue injury/contusion of the upper or lower limb
- •2. location of injury such that pain on movement (POM) is elicited on passive manipulation of nearest joint by investigator
- •3. enrolment within 6 hours of the injury
- •4. baseline VAS score for (investigator manipulated) POM of injured extremity >or equal to 50 mm on a 100 mm VAS
- •5. size of injury, as assessed by investigator, = 25 cm2 and = 120 cm2
- •6. adult male and female patients
- •7. age 18 to 60 years
- •8. having given written informed consent
- •9. 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 132
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •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. current 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 study start
- •6. intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
- •7. participation in a clinical study within 30 days before entry or concomitantly8. drug or alcohol abuse in the opinion of the investigator
- •9. Pregnant and 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 defined as:
- •? Surgical sterilization
- •? Hormonal contraception
- •? 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 vasomotor symptoms) 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.
- •11. known hypersensitivity to loxoprofen or one of the excipients of the plaster
- •12. patients with any ongoing condition that may interfere with the absorption, distributionmetabolism, or excretion of loxoprofen
- •13. history of previous significant injury to the same extremity 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. 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).
- •19. patients with a blood coagulation disorder
- •20. patients who use any impermissible medication (Use of systemic or topical NSAIDs, analgesics (other than paracetamol), opioids, corticosteroids (except for topical treatment of bronchial asthma), heparin, or psychotropic agents. Furthermore the application of ice or cooling packs to the injured area after randomization is not permitted
研究者
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