The safety of twice daily Oxycodone ORF tablets in 6-16 year olds

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter 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

• IRAS ID

  58711

• Sponsor organisation

  Purdue Pharma L.P.

• Eudract number

  2010-020471-23

• Research summary

  A STUDY TO ASSESS THE SAFETY AND EFFICACY OF OXYCODONE HYDROCHLORIDE CONTROLLED-RELEASE TABLETS IN PAEDIATRIC PATIENTSThis is a phase 3, open label study, designed to investigate the safety and efficacy of the study drug - oxycodone hydrochloride controlled-release- in paediatric patients aged 6-16 years old. The study drug is not approved for use in children and its safety and efficacy in patients below the age of 18 years has not been established. While oxycodone has been used by paediatric pain specialists for pain relief, current data is limited. The information learned from this study may help paediatric physicians to understand the study drug safety and efficacy in children. Patients who are outpatient or inpatient and who have been exposed to or treated with the equivalent of at least 20 mg of oxycodone daily for at least 48 hours before beginning study treatment may be included in the study. Patients must have moderate to severe malignant and/or nonmalignant pain requiring opioid therapy. The study includes a total of up to 3 hospital visits and additional telephone interviews. The patient will have a follow-up phone call or visit 7-10 days after the last visit. Participants will be in the study for up to 5 weeks and will be treated for a minimum of 2 weeks and up to 4 weeks with the appropriate daily dose of oxycodone HCI CR. Dose adjustments may be made during treatment. Supplemental opioid and non-opioid pain medication will be permitted during the study. Participants will undergo a number of assessments including, but not limited to clinical laboratory tests, vital signs, pain assessments, etc.The study will be conducted at up to 75 sites worldwide, enrolling a target number of approximately 100 participants.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  11/YH/0037

• Date of REC Opinion

  31 May 2011

• REC opinion

  Further Information Favourable Opinion