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.

• Conditions: Opioid experienced paediatric patients with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.; MedDRA version: 12.1Level: LLTClassification code 10002182Term: Analgesia

• Registration Number: EUCTR2010-020471-23-FI
• Lead Sponsor: Purdue Pharma L.P.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-21
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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 experienced, ie, have been treated with the equivalent of at least 20 mg daily dose of oxycodone during at least the last 48 hours prior to the screening visit (start of study drug) and have tolerated the therapy, as demonstrated at the screening visit (start of study drug) 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:
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

Exclusion Criteria

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 received epidural opioids <12 hours prior to the first dose of study drug;
4) Patients who are currently taking any medications which are CYP3A4 inhibitors;
5) Patients who have a history of sleep apnea within the past year;
6) Patients who have a history of cystic fibrosis;
7) Patients who have a current history of malabsorption syndrome;
8) Patients who have a current history of paralytic ileus;
9) Patients who require mechanical ventilation;
10) Patients who are contraindicated for the use of opioids;
11) Patients who are contraindicated for blood sampling;
12) Patients who are currently being maintained on methadone for pain;
13) Patients who have a life expectancy of less than 2 weeks;
14) 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;
15) 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;
16) Patients with evidence of impaired renal function (serum creatinine > 2 times the upper limit of normal [ULN] for age);
17) 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;
18) Patients who, in the opinion of the investigator, are unsuitable to participate in this study for any other reason.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified