EUCTR2007-003848-30-IT进行中（未招募）不适用
Effects of a plaster containing diclofenac epolamine (DHEP) and heparin on the pain threshold in asymptomatic subjects (no spon-taneous pain) with a latent algogenic condition (subcutaneous and/or muscle hyperalgesia and dystrophic changes) of the lower limb. - 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
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
- •Subjects must have signed an informed consent document indicating that they understand the purpose and procedures of the trial, and that they are willing to participate in the trial. Males and non-pregnant, non-lactating females. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control according to the definition of Note 3 of ICH M3 (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner steriliza-tion, abstinence) before entry and throughout the trial. Female subjects must have a negative pregnancy test at screening. Aged between 18 and 65 years. Subjects with no spontaneous somatic pain since at least one month before enrolment. Hyperalgesia in deep somatic structures (latent algogenic condition, e.g., from previous knee microtraumatic events, latent myofascial trigger points) with: a) abnormally low pain threshold of vastus lateralis to electrical stimulation (< 4 mA); b) abnormally low pain threshold of vastus lateralis to local pressure (< 4 kg-f); c) abnormally low pain threshold to electrical stimulation of subcutis (< 2 mA). A 15-day washout from forbidden concomitant treatments (see exclusion criteria). Subjects cooperative and able to respect the scheduled procedures.
- •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
- •Subjects with diagnosis of asthma or any other type of hypersensitivity. Subjects with GI disturbances or disease that in the opinion of the Investigator could be negatively affected by the administration of a NSAID (e.g., gastritis, gastroduodenal ulcer, GI bleeding, etc). Subjects with significant cardiac impairment (i.e. severe heart failure, se-vere ischemic heart disease), history of cerebrovascular disease (i.e. ictus), history of peripheral arterial disease, uncontrolled hypertension (i.e. not stable = repeated measurements of systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg, despite pharmacological treatment). Subjects with any disorder of coagulation and haemostasis that could be negatively affected by the local administration of heparin or diclofenac. Subjects under treatment with any type of analgesic / anti-inflammatory / antirheumatic drug, or with any type of drug that is known to alter the pain threshold by any mechanism. Subjects under treatment with any type of drug affecting haemostasis (e.g., heparin, low molecular weight heparins, oral anticoagulants, mucopolysaccharides, etc). Concomitant use of drugs which may be susceptible to interactions with diclofenac or which may affect safety if used concomitantly (lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs and diuretics). History of significant liver insufficiency or inadequate hepatic function. Subjects with severely impaired renal function. Chronic hepatitis B or C, or HIV, or presence of active hepatitis B or C within the past 3 months.
研究者
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