計劃書編號A0081128
試驗已結束
2009-09-25 - 2011-09-27
Phase III
ICD-10C45.9
間皮瘤
ICD-10C79.9
未明示部位之續發性惡性腫瘤
ICD-10C7A.00
未明示部位之惡性類癌
ICD-10C7A.094
前腸惡性類癌
ICD-10C7A.095
中腸惡性類癌
ICD-10C7A.096
後腸惡性類癌
ICD-10C7A.1
分化不良型惡性神經內分泌腫瘤
ICD-10C7A.8
其他惡性神經內分泌腫瘤
ICD-10C7B.00
未明示部位續發性惡性類癌
ICD-10C80.1
未明示惡性腫瘤（原發性）
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9199.1
未明示部位(原發性，續發性)之惡性腫瘤
一隨機、雙盲安慰劑臨床試驗：用於評估彈性劑量給予Pregabalin，在治療癌症引起的骨疼痛的療效和安全性
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試驗委託 / 贊助單位名稱
N/A
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臨床試驗規模
多國多中心
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更新日期
2026/03/01
試驗主持人及試驗醫院
適應症
癌症轉移性骨疼痛。
試驗目的
主要：評估pregabalin依據療效與耐受性設定的可調整劑量，與安慰劑比較對癌症轉移性骨疼痛患者的療效。
次要：評估pregabalin一日兩次對癌症轉移性骨疼痛受試者的安全性與耐受性。
藥品名稱
膠囊劑
主成份
Pregabalin
劑型
130
劑量
50mg/75mg/150mg/300mg
評估指標
Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28
主要納入條件
Inclusion Criteria:
Patient must have a malignant, solid tumor that has been diagnosed as having metastasized to bone, and must have moderate to severe pain secondary to the bone metastasis at an identifiable reference site.
Patient must have a malignant, solid tumor that has been diagnosed as having metastasized to bone, and must have moderate to severe pain secondary to the bone metastasis at an identifiable reference site.
主要排除條件
Exclusion Criteria:
The patient who has undergone diagnostic or therapeutic invasive interventions (angiography, biopsy, surgery) less than 15 days prior to study start that would impact their assessment of pain at the reference pain site or area, in the opinion of the investigator.
The patient who has undergone diagnostic or therapeutic invasive interventions (angiography, biopsy, surgery) less than 15 days prior to study start that would impact their assessment of pain at the reference pain site or area, in the opinion of the investigator.
試驗計畫預計收納受試者人數
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台灣人數
21 人
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全球人數
310 人
