Study of the safety of the long-acting opioid pain medication Oxycodone hydrochloride in children who have been treated previously with opioid pain medication who completed the OTR3001 study

• Conditions: Opioid experienced paediatric patients aged 6-17 years with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.; MedDRA version: 14.0Level: LLTClassification code 10002182Term: AnalgesiaSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-002235-26-GR
• Lead Sponsor: Purdue Pharma L.P.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-13
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

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: 135
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) 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 are cyanotic postoperatively;
8) Patients who have a history of sleep apnea within the past year;
9) Patients who have a history of cystic fibrosis;
10) Patients who have a current history of malabsorption syndrome;
11) Patients who have a current history of paralytic ileus;
12) Patients who require mechanical ventilation;
13) Patients who are contraindicated for the use of opioids;
14) Patients who are currently being maintained on methadone for pain;
15) Patients who have a life expectancy of less than 2 weeks;
16) 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;
17) 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;
18) Patients with evidence of impaired renal function (serum creatinine > 2 times the upper limit of normal [ULN] for age);
19) 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;
20) Patients who, in the opinion of the investigator, are unsuitable to participate in this study for any other reason;
21) Patients currently taking an investigational medication/therapy other than the study drug (oxycodone HCL CR) at the start of screening or during the study.

Study & Design

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