EUCTR2009-013864-37-HU进行中（未招募）不适用
A randomized, multicenter, double-blind, parallel study to compare the efficacy and safety profile of RGH-507 (tolperisone-containing) gel versus a ketoprofen-containing gel in the treatment of patients with soft tissue injuries.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Acute (within 48 hours) soft tissue injury (traumatism or contusion) which accompanies signs of inflammation and pain in one of the extremities, with or without functional loss, with intact skin and requiring local treatment only.
- •The maximum spontaneous pain intensity score is =30 mm on the 100 mm pain intensity VAS during the period of 24 hours prior to the randomization, and/or the average spontaneous pain intensity score is =30 mm on the 100 mm pain intensity VAS during the period of 24 hours prior to the randomization.
- •Age between 18 and 75 years (inclusive both males and females).
- •18 kg/m2 = BMI = 35 kg/m2 (and the minimal body weight is 40 kg)
- •Signed Inform Consent.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •If the injury requires permanent occlusive dressing or surgical intervention or physiotherapy.
- •Uncontrolled hypertension (systolic > 180 mmHg, diastolic > 110 mmHg).
- •If QTc > 500 msec.
- •Known hypersensitivity to tolperisone or ketoprofen or other NSAIDs or fenofibrate or any of the other ingredients of the study medications,
- •Asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
- •Any medication to relieve the pain (either systemic or local) must have been discontinued for a period of at least 5 half-life of the drug prior to the enrolment and are not allowed during the whole study period (the list of drugs with their half-life see detailed in section 10.6 Concomitant therapy).
- •Any syndrome or alteration which can significantly interfere with the local pain or generate unresolved considerations in its differential.
- •Active arthritis in the affected limb.
- •Infected skin or fractures, underlying dermatitis or dermatosis associated with the injury.
- •Neurologic alterations of different origin which significantly affect the sensory or motoric functions (e.g. diabetic neuropathy).
- •History of drug or alcohol abuse within the past 2 years or current chronic or intermittent users of illicit drugs.
- •Lactating or pregnant women or women of child-bearing potential* without appropriate contraceptive treatment. Appropriate contraceptive methods are: abstinence or practicing a reliable method of contraception, such as: hormonal contraception (oral contraceptives consisting of an estrogen-progestin combination or progestin alone, transdermally delivered contraceptives, depot injections, intrauterine device), diaphragm+spermicid, condom+spermicid, vasectomised partner.
- •Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study or to cooperate on the necessary level.
- •Evidence of an uncooperative attitude.
- •Patients who have participated in a study of an investigational drug or device within 3 months of this study.
- •*women without child-bearing potential: if her menstruation have been missing at least 1 year before the screening or she is infertile because of a gynaecological surgical intervention (tubal ligation or hysterectomy).
研究者
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