EUCTR2005-005863-26-GB进行中（未招募）1 期
A Phase II, double blind, placebo controlled, dose-ranging study in patients with post herpetic neuralgia (PHN) to evaluate the efficacy, safety, tolerability and pharmacokinetics of four doses of TAK-583, compared with placebo.
Takeda Global Research & Development Centre (Europe) Ltd0 个研究点目标入组 0 人开始时间: 2006年3月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
入选标准
- •1.Male and female subjects with PHN whose pain has been present for >3 months following healing of the herpes zoster rash.
- •2.Subjects with an mean pain intensity score of 4 or more (determined from at least 4 daily recordings of pain intensity on an 11-point numerical scale over the preceding 7 days) during the baseline phase.
- •3.Subjects aged 50 years and above.
- •4.The female subject is postmenopausal.
- •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
- •1.Malignancy within the past 2 years with the exception of basal cell carcinoma.
- •2.Subjects who have undergone neurolytic or neurosurgical therapy for PHN.
- •3.Clinically significant, actively treated or unstable hepatic, biliary, respiratory, renal, rheumatologic, or hematologic illnesses, or unstable cardiovascular disease as assessed by the investigator.
- •4.WBC <2500, ANC <1500, platelets <100,000; ALT, AST or alkaline phosphatase >1.5x ULN; total bilirubin =1.2x ULN (excluding Gilbert’s Disease); predicted GFR using MDRD formula = 45 mL/min.
- •5.Subjects with > 5 RBCs per high-power field on urinalysis.
- •6.Subjects with an albumin/creatinine ratio in an untimed (spot”) morning urine specimen >ULN.
- •7.Subjects who are immunocompromised or have clinically significant haematological abnormalities.
- •8.Subjects with a history of HIV infection.
- •9.Subjects with a positive hepatitis panel (including hepatitis B surface antigen, antibody to hepatitis B core antigen, antibody to hepatitis B surface antigen, or antibody to hepatitis C virus), except subjects with positive antibodies to hepatitis B surface antigen who have received hepatitis B vaccination and who have no history of serological evidence of liver disease.
- •10.Subjects having other severe pain which may impair the self assessment of the pain due to PHN.
- •11.Subjects who have participated in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline.
- •12.Subjects who have received TAK-583 in a previous clinical study.
- •13.Subjects who have donated more than 400 mL of blood in the 90 days prior to the beginning of the study.
- •14.Subjects who have a history of alcohol or illicit drug abuse in the past 2 years
- •15.Clinically significant abnormal 12 lead ECG. A QTc >450 ms that is confirmed on a repeat ECG is considered cllinically significant
- •16.Subjects who have skin conditions in the affected dermatome that could alter sensation.
- •17.Subjects who have taken any excluded substances (prescription or non-prescription) in the timeframe specified in Section 7.3 (Excluded Medications).
- •18.Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study.
- •19.The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, sibling) of a study site employee involved in conduct of this study.
研究者
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