EUCTR2005-005555-17-GB进行中（未招募）1 期
[S,S]-REBOXETINE ADD-ON TRIAL: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL OF [S,S]-REBOXETINE IN PATIENTS WITH POSTHERPETIC NEURALGIA (PHN) CONCOMITANTLY TREATED WITH PREGABALIN. - NA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Ltd
- 入组人数
- 361
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, at least 18 years of age
- •·Female patients must be non-pregnant and non-lactating, and be either postmenopausal, surgically sterilized, or using an appropriate method of contraception (including barrier or hormonal method). Women of childbearing potential must have a confirmed negative urine pregnancy test at the Screening visit (Visit 1)
- •·Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash. There is no upper limit on the duration of PHN
- •·Patients at screening visit (Visit 1) must have a score =40 mm on the Pain Visual Analogue Scale (VAS)
- •·Patients must be able to understand and cooperate with trial procedures and have signed a written informed consent document prior to entering the trial
- •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
- •·Malignancy within the past 2 years with the exception of basal cell carcinoma
- •·Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for PHN
- •·Creatinine clearance <30 Ml/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation)
- •·Patients with significant hepatic impairment (i.e. AST/ALT >2 x ULN, Total bilirubin >2 x ULN)
- •·Platelet count <100 x 10E3/mm3; white blood cell (WBC) count <2.5 x 10E3/ mm3; neutrophil count <1.5 x 10E3/ mm3
- •·History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection
- •·Patients having other severe pain, which may impair the self-assessment of the pain due to PHN
- •·Patients who have a history of alcohol or drug abuse in the past 2 years
- •·Clinically significant abnormal 12-lead ECG
- •·Skin conditions in the affected dermatome that could alter sensation, other than PHN
- •·Use of prohibited medications in the absence of appropriate washout periods
- •·History or current episode of major depressive disorder as defined by DSM-IV diagnostic criteria
- •·Depression sub-scale score >10 on the Hospital and Anxiety Depression Scale
- •·History of recurrent syncope or evidence of low blood pressure (<90 mmHg systolic or <40 mmHg diastolic)
- •·Evidence of symptomatic postural hypotension. This includes relevant postural symptoms associated with fall in systolic blood pressure of >20 mmHg or diastolic blood pressure >10 mmHg on standing (from sitting)
- •·Patients with a history of transient ischemic attacks, stroke, or the presence of a carotid bruit (unless significant carotid stenosis (>70%) has been ruled out by appropriate investigation)
- •·History of uncontrolled narrow angle glaucoma
- •·Patients judged clinically to be a serious suicidal risk
- •·Patients who have a history of a seizure disorder
- •·Previous exposure to either pregabalin or RBX
- •·Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to Visit 1
- •·Have ever received treatment with vigabatrin, hydroxychloroquine, deferoxamine, thioridazine and or any compound known to adversely affect retina and visual fields
- •·Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the trial
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