An Open-label, Multicentre Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children from Ages 6 to 16 Years Old, Inclusive, with Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics.

Purdue Pharma L.P.0 个研究点目标入组 154 人开始时间: 2010年9月20日最近更新: 2015年8月4日

适应症

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 16 years, inclusive, who are expected to require ongoing around-the-clock opioid treatment equivalent to at least 20 mg daily dose of oxycodone for at least 2 weeks for management of moderate to severe(based on the investigator’s judgment) malignant or nonmalignant pain;
•2) Patients must be opioid tolerant, ie, have been treated with opioids for at least the 5 consecutive days prior to dosing and with at least 20 mg daily of oxycodone or the equivalent during at least the last 48 hours
•prior to the start of study drug dosing and have tolerated the therapy, as demonstrated at the start of study drug dosing by:
•(a) A normal respiratory rate for age,
•(b) Pulse oximetry (SpO2) = 92% on room air, and
•(c) No significant (grade 3 or 4) opioid-induced somnolence based on the University of Michigan Sedation Scale (UMSS) and the investigator’s judgment;
•Patients who are currently using transdermal fentanyl should have been on the patch for at least 3 days before removing the patch and oxycodone HCl CR treatment can only be initiated at least 18 hours following the removal of the transdermal fentanyl patch.
•3) Patients must not require more than a 240 mg total daily dose of oxycodone HCl CR tablets;
•4) Patients must be willing and able to swallow the oxycodone HCl CR tablets whole;
•5) Patients must be able to understand and complete the age appropriate scale to rate pain intensity, ie, patients must not have a cognitive developmental delay or any other condition that would preclude them from completing age appropriate pain scale;
•6) Patients must have a parent/caregiver who can perform study assessments, including the assessment of UMSS, Functional Disability Inventory (FDI), and Parent/Caregiver-Assessed Global Impression of Change (PGIC); and record the assessment scores, each dose of oxycodone HCl CR tablets, and each dose of supplemental pain medication;
•7) Female patients of childbearing age must have a negative pregnancy test within 24 hours prior to study drug administration and be nonlactating;
•8) Female patients who are sexually active must be using an acceptable method of birth control;
•9) Patients and parents/caregivers who are willing and able to be compliant with the protocol, are capable of patient evaluation, are able to read and understand questionnaires, 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) Female patients who are pregnant or lactating;
•2) 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]);
•3) Patients who have had surgery within 5 days prior to Day 1 (day of first dose of study drug);
•4) Patients who have received epidural opioids < 2 hours prior to the first dose of study drug or who have received epidural morphine < 12
•hours prior to the first dose of study drug;
•5) Patients taking moderate to strong CYP3A4 inhibitors if the dose has not been stable for at least 1 month;
•6) Patients taking moderate to strong CYP3A4 inhibitors if the dose has been stable for at least 1 month but the adjusted starting dose
•determined for oxycodone HCl CR is less than 20mg daily;
•7) 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;
•8) Patients who, in the investigator's opinion, have an underlying gastrointestinal condition or other disorder that may predispose them to obtruction;
•9) Patients who are cyanotic postoperatively;
•10) Patients who have a history of sleep apnea within the past year;
•11) Patients who have a history of cystic fibrosis;
•12) Patients who have a current history of malabsorption syndrome;
•13) Patients who have a current history of paralytic ileus;
•14) Patients who require mechanical ventilation;
•15) Patients who are contraindicated for the use of opioids;
•16) Patients who are contraindicated for blood sampling;
•17) Patients who are currently being maintained on methadone for pain;
•18) Patients who have a life expectancy of less than 2 weeks;
•19) 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;
•20) 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;
•21) Patients with evidence of impaired renal function (serum creatinine > 2 times the upper limit of normal [ULN] for age);
•22) 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;
•23) Patients who, in the opinion of the investigator, are unsuitable to participate in this study for any other reason.
•24) Patients currently taking an investigational medication/therapy at the start of screening or during the study.

研究者

发起方

Purdue Pharma L.P.

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