EUCTR2009-015415-41-BE进行中（未招募）不适用
idocaine patches in postoperative and posttraumatic neuropathic chronic skin pain - A prospective, randomized, double-blinded, placebo-controlled, parrallel, multicentre, investigator initiated study according to clinical guidelines - PNCCP Study
niversitair Ziekenhuis Antwerpen (UZA) - Multidisciplinair Pijncentrum0 个研究点开始时间: 2010年3月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-NRS > or = 5 and LANSS < or = 12 (as ca clear sign of severe neuropathic pain);
- •-Neuropathic pain present for at least 3 months;
- •-Clinical diagnosis of postoperative or posttraumatic neuropathic cutaneous chronic pain, where the diagnosis is made by the referring doctor and/or study investigator (pain should be clearly related to nerve damage during surgical procedure or trauma in terms of both location and tim of occurence);
- •-The presence of cutaneous allodynia and/or hyperelgesia in the painful region;
- •-Most painful skin area should be coverable by a maximum of 3 plasters;
- •Presence of stable analgesic regimen (no change in this medication during 3 weeks before inclusion into the study);
- •-Negative urine pregnancy test for women of childbearing potential;
- •-Willingness of the patient to comply with the procedures of this clinical study, signing of an informed consent form and willingness to not increase the pre-existing analgesics (this is the average therapy in the period of one week prior to the start of the study) during the study period.
- •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 148
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •-Age < 18 or > 80;
- •-Patients not on a stable medication for at least 3 weeks;
- •-Patients not stable on a TENS treatment during the last 4 weeks, or any other treatment possibly confounding the evaluation of the study results;
- •-Patients continuing use of any topically applied pain relief compound;
- •-Pregnant women or lactating;
- •-Women of chilbearing potential not willing to use an adequate contraception method (all study duration);
- •-Infection in the painful version;
- •-Poorly healed or non-healed wound or scar in the painful region;
- •-Presence of exclusevely negative sensory symptoms (such as hypoesthesia);
- •-The current presence of another chronic pain syndrome that is clincally more pronounced than the PNCCP and/or the opinion of the study investigator that another chronic pain syndrome is present in the patient which may have a significant impact on the evaluation by the patient of the effect of the study medication on the PNCCP;
- •-The presence of postherpetic neuralgia;
- •-The presence of postlamniectomy syndrome namely failed back or neck surgery syndrome with radiculopathy.;
- •-The presence of another form of neuropathic pain and, in particular, painful sensory peripheral polyneuropathy;
- •-Clinical suspicion and/or known presence of sensory disturbances present prior to the occurence of the PNCCP, for example in diabetes mellitus, polyneuropathy due to alcohol, radiation, radiotherapy, chemotherapy etc..(except for patients being in remission, having received for more than 2 years no active cancer treatment);
- •-The presence of neurological disorders such as multiple sclerosis, CVA, spinal and/or brain disorders;
- •-Known and/or strong suspicion of allergy to the study medication, known skin disorder;
- •-Patients using steroid therapy;
- •-History of or present cognitive and/or psychiatric disorder with possible impact on the reporting of the effect of the study medication by the patient;
- •-Patients with ongoing medication litigation procedures are also excluded;
- •-Other reasons according to the estimations of the investigator which may put the study subjects at risk or preclude adherence to the trial protocol.
研究者
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