EUCTR2010-023883-42-IT进行中（未招募）不适用
Randomized, double-blind, placebo controlled trial to evaluate the efficacy of high dose intravenous immunoglobulins in diabetic painful polyneuropaty (DPNP)resistant to conventional therapies - IGD002
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2012年3月8日最近更新:
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
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
- •Patients males and females, age> 18 years; Outpatients; Diagnosis of painful diabetic polyneuropathy for at least 6 months up to a maximum of 5 years, confirmed according to the criteria of the Expert Group Toronto Diabetic Neuropathy; intensity of pain > 60 units in the visual-analogue scale (VAS) at baseline; DN4 questionnaire to score = 4; Prior treatment with NSAIDs, tricyclic antidepressants and anticonvulsants, and unsatisfactory results despite the achievement of therapeutic doses (pain reduction less than 30% to rating scale) or who have failed to take prescribed treatments for intolerable side effects, patients who have given written informed consent. Second phase of inclusion: Average pain assessment = 60 mm in the VAS during the 7 days after baseline. At least 50% of the diary must be completed to assess the patient's inclusion in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Any condition that, in the opinion of the investigator, may affect the patient's participation in the study, presence of other types of pain that may confound the assessment of painful polyneuropathy, patients treated with IVIg for six months at study Patients with Serum IgA <70 mg / dL; Cardiovascular disease failure, or uncontrolled by drug therapy, renal failure, liver failure, severe alterations of the Peripheral blood counts (leukopenia, thrombocytopenia, pancytopenia), psychiatric disease, amputations, pregnancy and lactation; Participation in clinical trials in the 30 days preceding the beginning of this study. Second phase inclusion Media> 60 mm in the VAS during the 7 days after baseline. At least 50% of the diary must be completed to assess the patient's inclusion in the study.
研究者
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