临床试验/NCT02321319

NCT02321319终止3 期

An Open-Label, Safety and Pharmacokinetic Study of Hydromorphone Hydrochloride Extended-Release Tablets (Once-Daily Hydromorphone) in Opioid-Tolerant Pediatric Subjects With Chronic Pain

Mallinckrodt3 个研究点分布在 1 个国家目标入组 5 人开始时间: 2017年3月11日最近更新: 2020年5月21日

适应症

干预措施

试验速览

阶段: 3 期
状态: 终止
发起方: Mallinckrodt
入组人数: 5
试验地点: 3
主要终点: Number of Participants With Adverse Events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic painful conditions who are "opioid-tolerant" prior to enrollment under the Pediatric Research Equity Act (PREA) of 2003.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 7 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Hydromorphone HCl ER Tablets

Experimental

Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)

干预措施: Hydromorphone HCl ER Tablets (Drug)

结局指标

主要结局

Number of Participants With Adverse Events (AEs)

时间窗: 28 days

Clinically significant changes in vital signs, pulse oximetry, and/or clinical laboratory assessments, were recorded as AEs

次要结局

未报告次要终点

研究者

发起方

Mallinckrodt

申办方类型

Industry

责任方

Sponsor

研究点 (3)

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