EUCTR2007-003372-18-IT进行中（未招募）不适用
A randomised, double-blind, placebo controlled study to assess the safety and the efficacy of neridronate 100 mg - 4 i.v. infusions in a course of 10 days treatment - in patients with algodystrophic syndrome. - ND
ABIOGEN PHARMA0 个研究点开始时间: 2008年1月7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
- •Male or female patients aged 18 years or greater Patients with confirmed diagnosis of AS according to IASP modified criteria and as evidenced by a bone scintigraphy performed within 4 months before study entry. Disease duration ≤ 4 months Patients with spontaneous pain (100 mm VAS scale) > 50 mm in the affected limb (or in the selected limb) Opioid analgesics, non-opioid analgesics, NSAIDs, anticonvulsants, antidepressant drugs and other non-drug therapies may be continued provided the dose is stable for at least 4 weeks before treatment start. Women of childbearing potential must have a negative pregnancy test (urine) before entering the study Women of childbearing potential must agree not to become pregnant and to breastfeed throughout the study period. Signature of written Inform Consent Form before any screening 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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Documented peripheral neuropathy, including diabetic neuropathy and other metabolic or toxic neuropathies Bilirubin, ALT, AST, alkaline phosphatase levels > 2 ULN at Visit 1 Current signs or symptoms of severe and/or progressive or uncontrolled hepatic, renal, endocrine, hematological, cardiac pulmonary, neurological disease Any other serious medical condition or laboratory abnormality or psychiatric illness preventing the patient from signing the Informed Consent Form Prior development of an allergic reaction/hypersensitivity while administered bisphosphonates Prior treatment with neridronate
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