計劃書編號A6061021
試驗已結束
2006-07-01 - 2007-12-30
Phase II
終止收納3
合併[S,S]-Reboxetine治療之臨床試驗: 以[S,S]-Reboxetine給予合併接受pregabalin治療之帶狀疱疹後神經痛病患的雙盲/隨機/安慰劑對照/多中心進行之臨床試驗
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試驗委託 / 贊助單位名稱
輝瑞大藥廠股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 終止收納
實際收案人數
0 終止收納
適應症
帶狀疱疹後神經痛 (Postherpetic Neuralgia)
試驗目的
●比較pregabalin合併[S,S]-RBX與單獨使用pregabalin對PHN病人的治療效果。
●調查評估以pregabalin合併[S,S]-RBX治療PHN病人的安全性和耐受性。
藥品名稱
錠劑
主成份
[S,S]-Reboxetine
劑型
110
劑量
1,2,4,6
評估指標
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated
主要納入條件
· 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
· 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
主要排除條件
· 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
· 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
試驗計畫預計收納受試者人數
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台灣人數
24 人
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全球人數
900 人
