An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study

Purdue Pharma L.P.0 个研究点目标入组 154 人开始时间: 2011年9月13日最近更新: 2014年5月12日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Purdue Pharma L.P.
入组人数: 154

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

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1) Male and female patient aged 6 to 17 years, inclusive, who completed the 4-week study drug treatment in study OTR3001 and who, based on the investigator's judgment, will benefit from continuing treatment with oxycodone HCL CR 20 to 240 mg/day for the management of moderate to severe malignant or nonmalignant pain;
•2) Patients must have tolerated the oxycodone HCL CR therapy in OTR3001 as demonstrated at the start of the study by:
•A normal respiratory rate for age;
•No significant (grade 3 or 4) opioid-induced somnolence at visit 1 based on the University of Michigan Sedation Scale (UMSS) and the investigator’s judgment;
•The clinical judgment of the investigator;
•3) Patients must be willing and able to swallow the oxycodone HCl CR tablets whole;
•4) Female patients of childbearing age must have a negative pregnancy test at visit 3 of OTR3001 and must be nonlactating;
•5) Patients must have a parent/caregiver who can perform all study assessments, including the UMSS assessment, and record the doses of oxycodone HCl CR tablets, and doses of supplemental pain medication;
•6) Female patients who are sexually active must be using an acceptable method of birth control;
•7) Patients and parents/caregivers who are willing and able to be compliant with the protocol, are capable of patient evaluation, are willing and able to use a diary, and are able to read, understand, and sign the written informed consent and/or assent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 154
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1) Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion, disqualifies then from participation in the study;
•2) Female patients who are pregnant or lactating;
•3) Patients requiring opioid at doses equivalent to < 20 mg/day or > 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain;
•4) Patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation]);
•5) Patients taking moderate to strong CYP3A4 inhibitors if the dose has not been stable for at least 1 month;
•6) Patients for whom it is anticipated that therapy with a moderate to strong CYP3A4 inhibitor will be initiated during the study, after the screening visit;
•7) Patients who, in the investigator's opinion, have an underlying
•gastrointestinal condition or other disorder that my predispose them to obstruction;
•8) Patients who are cyanotic postoperatively;
•9) Patients who have a history of sleep apnea within the past year;
•10) Patients who have a history of cystic fibrosis;
•11) Patients who have a current history of malabsorption syndrome;
•12) Patients who have a current history of paralytic ileus;
•13) Patients who require mechanical ventilation;
•14) Patients who are contraindicated for the use of opioids;
•15) Patients who are currently being maintained on methadone for pain;
•16) Patients who have a life expectancy of less than 2 weeks;
•17) Patients who have an abnormality on vital signs, physical
•examination, or laboratory testing significant enough that the
•investigator deems the patient is not appropriate for the study;
•18) Patients with hepatic impairment as evidenced by serum alanine amino transferase (ALT) or serum aspartate amino transferase (AST) > 5 times the upper limit of normal (ULN) for age;
•19) Patients with evidence of impaired renal function (serum creatinine
•> 2 times the upper limit of normal [ULN] for age);
•20) Patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices;
•21) Patients who, in the opinion of the investigator, are unsuitable to participate in this study for any other reason;
•22) Patients currently taking an investigational medication/therapy
•other than the study drug (oxycodone HCL CR) at the start of screening or during the study.

研究者

发起方

Purdue Pharma L.P.

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