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临床试验/EUCTR2006-001343-55-LT
EUCTR2006-001343-55-LT进行中（未招募）不适用

A PHASE 2B LONG-TERM, RANDOMIZED, OPEN-LABEL, SAFETY AND TOLERABILITY TRIAL COMPARING [S,S]-REBOXETINE (PNU-165442G) WITH ROUTINE CARE IN PATIENTS WITH POSTHERPETIC NEURALGIA (PHN). - N/A

Pfizer Luxembourg SARL Branch Office in Lithuania0 个研究点目标入组 600 人开始时间: 2006年10月10日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
600
研究概览入排标准研究者记录与标识符相似试验

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 of any race at least 18 years of age.
  • •· Female patients must be postmenopausal, or surgically sterilized, or (if they are of childbearing potential) they must be nonpregnant and nonlactating and must be using appropriate methods of contraception (including barrier or hormonal method). Women of childbearing potential must have a confirmed negative urine pregnancy test at the screening visit (V1) and at the randomization visit (V2).
  • •· 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 V1 must have a score =40 mm on the Pain Visual Analogue Scale (VAS).
  • •· Normal chest x-ray within 1 year prior to V1; or stable x-ray defined as no clinically significant change from previous exam (if none available, x-ray must be taken at V1).
  • •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 with significant hepatic impairment (i.e. AST/ALT>2x ULN, Total bilirubin >2 x ULN)
  • •· Clinically significant abnormal 12-lead ECG (in the opinion of the investigator).
  • •· Neurological disorders unrelated to PHN that may confuse the assessment of neuropathic pain.
  • •· Any pain or other condition that may confound assessment or self-evaluation of the pain due to PHN.
  • •· History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection.
  • •· Skin conditions in the area affected by the neuropathy that (in the opinion of the investigator) could alter sensation.
  • •· Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for PHN.
  • •· Amputations other than toes.
  • •· Administration of any investigational drug and/or agent within 30 days prior to screening.
  • •· Use of prohibited medications, in the absence of appropriate washout phases.
  • •· Abuse of drugs or alcohol within the last 2 years.
  • •· Any serious or unstable medical conditions that, in the opinion of the investigator, would compromise participation in the trial.
  • •· Any history of, or current, significant psychiatric disorder e.g. any DSM-IV Axis I or II Disorder or patients judged clinically to be a serious suicidal risk.
  • •· History of recurrent syncope or hypotension (systolic <90mmHg, diastolic <40mmHg).
  • •· Postural hypotension (a fall of 20mmHg in systolic BP or 10mmHg in diastolic BP on standing).
  • •· History of transient ischemic attack or stroke.
  • •· Carotid bruit, unless significant carotid stenosis (e.g. >70%) has been excluded by appropriate investigation.
  • •· History of uncontrolled narrow angle glaucoma.
  • •· History of epilepsy or seizure disorder.
  • •· Previous exposure to reboxetine.
  • •· History of urinary retention or prostatic hypertrophy (unless surgically corrected e.g. by TURP).
  • •· History of heart failure (NYHA class =2), myocardial infarction or unstable angina.

研究者

发起方
Pfizer Luxembourg SARL Branch Office in Lithuania

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