EUCTR2020-005217-41-DE进行中（未招募）1 期
Randomized, controlled, multi-center trial to evaluate the efficacy and safety of a Flurbiprofen 40 mg cutaneous hydrogel medicated plaster vs. placebo and vs. a marketed active comparator in the local symptomatic and short-term treatment of pain in acute strains, sprains or bruises of the soft tissues following blunt trauma, e.g. sports injuries
ead Chemical Company Ltd0 个研究点目标入组 312 人开始时间: 2021年5月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 312
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
- •2.location of injury such that pain on movement (POM) is elicited on passive manipulation of nearest (or involved) upper or lower limb joint by 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
- •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: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 concomitantly
- •8.drug or alcohol abuse in the opinion of the investigator
- •9.pregnant and lactating women
- •10.women of child-bearing potential who are not using an acceptable method of contraception
- •11.known hypersensitivity to flurbiprofen, diclofenac sodium or one of the excipients of the plasters.
- •12.history of NSAID-associated bronchospasm
- •13.patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of flurbiprofen or diclofenac sodium.
- •14.history of previous significant injury to the same limb within 6 months.
- •15.patients with a disease affecting the same limb, such as synovitis, rheumatoid arthritis, arthrosis, etc.
- •16.patients having an ongoing painful condition associated with sports-related injury/contusion.
- •17.patients suffering from symptoms of an infectious disease including swelling of any joint of the affected upper or lower limbs.
- •18.patients who had surgery of the affected upper or lower limb within one year of study entry.
- •19.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).
- •20.patients with a blood coagulation disorder.
- •21.patients who use any impermissible medication.
研究者
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