Phase III study of HFT-290 in pediatric patients with cancer

Hisamitsu Pharmaceutical Co., Inc.0 个研究点目标入组 11 人开始时间: 2018年4月2日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Hisamitsu Pharmaceutical Co., Inc.
入组人数: 11

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

Cancer patients aged 2-19 years being treated with strong opioid analgesics were switched to HFT-290 for 2 weeks. Serum fentanyl concentration was measured at steady state. A total of 11 patients were enrolled. No patient received a dose exceeding 2 mg. Mean serum fentanyl concentrations after administration of 0.5, 1, and 2 mg were 144 (n = 4), 277 (n = 3), and 2070 pg/mL (n = 4), respectively. No respiratory adverse events were observed, and pain was well controlled.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 2age old 至 <= 19age old（—）
性别: All

入选标准

•Pediatric patients confirmed to have various types of cancer.

排除标准

•- Patients with any cutaneous abnormalities at the planned application site that could be aggravated by application of the investigational product.
•- Patients with serious cardiac, hepatic, or renal dysfunction, serious respiratory disorders, or severe respiratory depression.

研究者

发起方

Hisamitsu Pharmaceutical Co., Inc.

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