Study of the safety of the long-lasting opioid pain medication Oxycodone hydrochloride in children (age 6-16) which have been treated previously and are used to opioid pain medication, and are suffering from moderateto severe pain.
- Conditions
- Opioid tolerant paediatric patients with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.MedDRA version: 14.1Level: LLTClassification code 10002182Term: AnalgesiaSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-020471-23-HU
- Lead Sponsor
- Purdue Pharma L.P.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 154
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method