EUCTR2014-001156-28-IT进行中（未招募）1 期
A randomized, double-blind, placebo controlled study to assess the safety and the efficacy of Neridronate ampoules 25 mg, after repeated intramuscular administrations, in patients with Complex Regional Pain Syndrome type I (CRPS-I) - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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 outpatients aged 18 years or greater;
- •Patients with confirmed diagnosis of CRPS-I according to the International Association for the Study of Pain (IASP) criteria, i.e. the validated Budapest 2007 criteria (Harden et al, 2007, Appendix I) for research purposes and as evidenced by 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 selected extremity (hand, foot, ankle);
- •Opioid analgesics, non-opioid analgesics, NSAIDs, anticonvulsants, antidepressant drugs and other non-drug therapies may be continued during the the double-blind phase provided the dose is stable for at least 4 weeks before treatment start;
- •Women of childbearing potential must have a negative pregnancy test (serum) before entering the study;
- •Women of childbearing potential must agree not to become pregnant and to breastfeed throughout the study period;
- •Patients with a co-operative attitude and able to adhere to study treatment and study protocol procedures and timelines;
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
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 the screening visit (Visit 0);
- •Current signs or symptoms of severe and/or progressive or uncontrolled hepatic, renal, endocrine, haematological, cardiac pulmonary, neurological disease based on investigator judgement;
- •Any other serious medical condition or laboratory abnormality or psychiatric illness preventing the patient from signing the Informed Consent Form;
- •Recent tooth extraction (in the past 3 months prior to Visit 1), unhealed or infected extraction site, significant dental/periodontal disease that may pre-dispose to need for tooth extraction or other invasive dental procedures during the trial;
- •Evidence of denture-related gum trauma or injury;
- •Prior development of an allergic reaction/hypersensitivity while administered bisphosphonates;
- •Prior treatment with bisphosphonates in the previous 12 months;
- •Allergy, sensitivity or intolerance to study drug and/or study drug formulation ingredients;
- •Patients unable to give a valid informed consent;
- •Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- •Patients who received any investigational new drug within the last 12 weeks;
- •Patients who have been previously enrolled in this study;
- •Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
研究者
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