EUCTR2012-000058-73-GB进行中（未招募）1 期
A multi-centre (UK) double-blind randomised parallel group placebo controlled trial to evaluate the efficacy, safety, and tolerability of Intravenous Immunoglobulin (IVIg) 0.5g/kg plus standard treatment, versus matched placebo plus standard treatment in patients with longstanding Complex Regional Pain Syndrome. - Low-dose Intravenous Immunoglobulin Treatment for CRPS (LIPS Trial)
niversity of Liverpool0 个研究点目标入组 111 人开始时间: 2012年8月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 111
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
入选标准
- •1.Diagnosis of Complex Regional Pain Syndrome I or II according to Budapest research criteria (appendix 5) (22).
- •2.Disease duration of 1-5 years and a mean pain intensity on an 11-point (0-10) Numeric Rating Scale (NRS) over the first seven daily entries after screening within a pre-defined range (see section 9 for details of pain thresholds for eligibility)
- •3.Failure to respond (poor efficacy or unacceptable side effects) to drugs recommended for the treatment of neuropathic pain (23), including pregabalin or gabapentin, a tricyclic antidepressant, and mild and strong opioids (where not contraindicated or refused by the patient).
- •4.Previous specialised pain physiotherapy (24), including desensitisation techniques, and either mirror therapy (25) or graded motor imagery treatment (26), or both (where not contraindicated or refused by the patient).
- •5.Willingness to confirm the use of adequate birth control while on the trial will be required in pre menopausal women without evidence for an inability to become pregnant.
- •6.Willingness to not start any other treatment for during the parallel part of the trial
- •7.Age 18 years and above
- •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 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Any individuals meeting any of the following will be excluded from the study:
- •1.Other significant chronic pains, which in the view of the study doctor may make assessment of the pain arising from CRPS difficult,
- •2.If the patient recently started a new therapy for CRPS, which in the view of the study doctor may change the patient’s pain level during the time of participation in the trial.
- •3.Unstable medical conditions
- •4.Litigation. Patients in litigation will be excluded only if conclusion of that litigation is imminent during the course of the study.
- •5.Pregnant or breastfeeding patients.
- •6.Complete IgA deficiency
- •7.Rare contraindications to IVIg therapy as per summary of product characteristics (SmPC)
- •8.Receiving IVIg for other reasons,
- •9.Patients previously enrolled in CRPS IVIg/SCIG trials
- •10.Drugs or alcohol abuse
- •11.Psychiatric or mental health disorder which could in the judgement of the site investigator interfere with successful study participation
- •12.Unwillingness or inability to complete daily diaries, or inability to understand the questionnaires being used.
- •13.Cancer other than basal cell carcinoma within the last 5 years. However those patients who have received definitive treatment, such as curative surgery more than 6 months ago, with no known recurrence can be included.
- •14.A history of hypercoagulable or thrombophilic clotting abnormalities.
- •15.A history of thrombembolic events: ischaemic stroke, confirmed myocardial infarction, pulmonary embolism; deep venous thrombosis except where immobility related (e.g. after injury or operation).
- •16.Unstable angina.
- •17. Renal failure, or serum creatinine greater than 1.5 times the upper limit of normal at screening.
- •18.Any medical condition which in the opinion of the investigator would make it unsafe for the patient to participate or which would interfere with assessment of the outcome measures.
- •19.Participation in another interventional trial within 3 months of randomisation. Participation in non-interventional studies is not a reason for exclusion.
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