An Open-label Study to Characterise the Pharmacokinetics and Safety of Oxycodone Hydrochloride q12h Controlled-Release Tablets (ORF) in Paediatric Patients Aged 6 to 16 Years Inclusive, Who Require Opioid Analgesia.

Conditions: Post operative and non-surgical paediatric patients, expected to or must have moderate to severe pain requiring oral opioid analgesic treatment for at least 24 hours. Patients must be inpatient for the treatment period of the study.
MedDRA version: 13.1Level: LLTClassification code 10002182Term: AnalgesiaSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 13.1Level: PTClassification code 10036276Term: Postoperative analgesiaSystem Organ Class: 10042613 - Surgical and medical procedures

Registration Number: EUCTR2010-020510-29-FI

Lead Sponsor: Purdue Pharma L.P.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

1. Have written informed consent provided by the parent or legal guardian and patient assent, when appropriate.
2. Children of either gender, aged 6 to 16 years, inclusive.
3. Have or are expected to have moderate to severe pain for an extended period of time requiring inpatient opioid analgesic treatment for at least 12 hours as this is the minimum duration of study period treatment.
4. Must be treated with an opioid for a minimum of 96 hours prior to the first dose of ORF.
5. In order to receive the first oral dose, patients must have respiratory stability, including a sustained SpO2 of at least 92% with or without supplemental oxygen during the 15 minute period just prior to dosing.
6. Must be inpatient for the treatment period of the study.
7. The patient’s anticipated opioid analgesic requirement over the first 12 hours that will follow administration of ORF must be equivalent to at least 10 mg of IV morphine.
8. Have adequate pain control during the 6 hours prior to study drug administration, based on appropriate clinical assessment.
9. Must be sufficiently alert to communicate and complete the FPS-R or 100-mm VAS.
10. Females who are sexually active must be using an adequate and reliable method of contraception.
11. If female and of child bearing potential, must have a negative pregnancy test and be non-lactating.
12. Must be able to swallow tablets whole.
13. Must have stable vital signs.
14. Must have vascular access to facilitate blood draws.
15. Must be willing and able to participate in all aspects of this study involving use of oral medications, patient evaluation, and phlebotomy, as evidenced by written informed consent from the parent or legal guardian and written patient assent when required by the local IRB/EC.
16. Must be willing to have up to 10 mL of blood collected for blood analysis (7 mL for primary PK and 3 mL for secondary PK analysis); and up to 10 ml of blood for pre-specified safety laboratory tests, without safety concerns.

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. Patients who have had surgery within 96 hours prior to the day of first dose of study drug.
2. Have any history of hypersensitivity or medical contraindication for the use of oxycodone (this does not exclude patients with a history of expected opioid-related AEs, such as light-headedness, dizziness, sedation, nausea, or vomiting).
3. Have any current history of medical or surgical conditions that might significantly interfere with the gastrointestinal absorption, distribution, metabolism, or excretion of oxycodone (this includes any history of serious disease of the gastrointestinal tract, liver, kidneys, and/or blood-forming organs).
4. Have received oxycodone in the 24 hours prior to study drug administration. (See Protocol Section 9.9, Excluded, Prior and Concomitant Medications and Therapies).
5. Have received epidural (or regional) anesthesia <12 hours prior to the first oral dose of ORF.
6. Patients who are cyanotic post-operatively.
7. Have a current history of malabsorption syndrome.
8. Have a current diagnosis of sleep apnea within the last year.
9. Have reduced renal function (serum creatinine > 1.8 X the upper limit of normal for age).
10. Have 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.
11. Are taking moderate to strong CYP3A4 inhibitors if the dose has not been stable for at least 1 month.
12. Are taking moderate to strong CYP3A4 inhibitors if the dose has been stable for at least 1 month but the adjusted starting dose determined for ORF is less than 10mg (see Protocol Section 9.7. Dose Conversions, Protocol Section 9.9. Excluded, Prior and Concomitant Medications and Therapies and Appendix I for a list of strong and moderate CYP3A4 inhibitors [as per FDA Guidance, 2006]).
13. 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 (see Protocol Section 9.9. Excluded, Prior and Concomitant Medications and Therapies and Appendix I for a list of strong and moderate CYP3A4 inhibitors [as per FDA Guidance, 2006]).
14. Have impaired respiratory reserve including severe acute or chronic lung disease, or patients receiving mechanical respiratory support, including mechanical ventilation, BIPAP, or CPAP 6 hours prior to the first oral dose and during the entire oral treatment period.
15. Have impaired cardiovascular stability (e.g., the day of surgery for cardiac surgery patients).
16. Are currently taking an investigational medication/therapy at the start of screening or during the study.
17. Are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.

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

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