EUCTR2006-003773-28-IT进行中（未招募）不适用
A multicentre, prospective, double-blind, in parallel groups randomised, versus placebo and versus reference product controlled, confirmatory clinical trial of the efficacy and tolerance of Flector Tissugel Heparine in the treatment of ankle sprains. - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- IBSA
- 入组人数
- 420
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
- •Outpatients of both gender, aged between 18 and 65 years, having an acute ankle sprain involving the lateral ligaments i.e. inversion mechanism , occurred during the 48 hours preceding inclusion in the study, with presence of peri-malleolar oedema difference between the sub-malleolar perimeter of injured and healthy ankle of at least 20 mm, when measured by means of a measuring tape and with pain on movement while performing normal daily activities 8805; 50 mm on a 100-mm VAS, without any previous treatment, will be included in the study, after having given their written informed consent to participation. Sprain must be benign in nature grade I or II according to the annexed classification and not requiring an orthopaedic or surgical treatment in case of doubt, a radiographic evaluation according to the Ottawa criteria will be done , nor a physiotherapeutic treatment other than standardised ice/cold packs application see section 5.2 . Anyway, the recourse to ice/cold packs applications will not be permitted during the study period.Female subjects of childbearing potential i.e., not status post hysterectomy or tubal ligation must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 and they must have a negative urine pregnancy test at screening/inclusion visit.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Major reasons for exclusion are presence of an open skin lesion within the injured area, presence of any dermatological condition affecting the site of plaster application, three or more prior injuries to the actually injured ankle in the past, relapsing sprains already treated during the 6 months preceding the study, prior use of any topical medication to involved area or prior use of OTC analgesic or NSAIDs ibuprofen, ketoprofen within 48 hours before study entry acetaminophen permitted , prior use of narcotic analgesics within 7 days before study entry, prior use of systemic anti-inflammatory steroidal drugs by any route of administration within 60 days preceding study entry, prior use of long-acting NSAIDs such as piroxicam or naproxene since injury, concomitant use of drugs which may be susceptible of interactions with diclofenac or which may affect safety if used concomitantly lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs and diuretics , patients with severe grade III ankle sprain or with sprain suggesting associated lesions, with acquired or congenital hyperlaxity, with history of dislocation or fracture or other diseases affecting the injured joint, or with surgery to the affected joint dated less than one year, patients with coagulation defects, with cardiac impairment, history of GI bleeds/ulcers or liver/kidney disease, known hypersensitivity to diclofenac or other NSAID drugs including aspirin or to paracetamol rescue medication , pregnant and breast-feeding women.
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