The safety of twice daily Oxycodone HCl CR tablets - Extension Study

• Research type

  Research Study

• Full title

  An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study

• IRAS ID

  85796

• Contact name

  Ayman N A H Eissa

• Sponsor organisation

  Purdue Pharma L.P.

• Eudract number

  2011-002235-26

• Research summary

  AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY OF TWICE DAILY OXYCODONE HYDROCHLORIDE CONTROLLED-RELEASE TABLETS IN PAEDIATRIC PATIENTS.This is an open-label, extension study to characterize the long-term safety of oxycodone HCl CR tablets in paediatric patients 6 to 17 years of age (inclusive). Historically, studies have reported that physicians, nurses, and parents underestimate the amount of pain experienced by infants, children and adolescents. However, they often overestimate the risks of the drugs used in the treatment of pain as well. Likely, as a result, children have frequently received inadequate treatment or, in some cases, no treatment at all, for the relief of pain. Chronic pain is a significant problem in the paediatric population, conservatively estimated to affect 15% to 20% of children. Unfortunately only a small number of analgesics have been studied in children, resulting in insufficient literature with regards to pharmacokinetics, pharmacodynamics, safety and efficacy. The duration of study drug treatment is up to 6 months. Only patients who completed the 4-week treatment period in OTR3001 study are eligible for this study. Upon entry into this study, patients may continue with the oxycodone HCl CR dose they received at the end of OTR3001 treatment period, or if necessary, have their doses adjusted by the investigator. Unlimited number of dose adjustments between oxycodone HCl CR 20 mg/day and oxycodone HCl CR 240 mg/day, inclusive, are permitted during the study until an optimal dose is achieved. Supplemental opioid and nonopioid pain medications, including any oxycodone-containing products, are permitted at the discretion of the investigator. Following the last dose of study drug, all patients will be contacted within 7 to 10 days for a safety follow-up assessment. The study will be conducted worldwide, enrolling a target number of approximately 135 participants.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  11/YH/0339

• Date of REC Opinion

  13 Jan 2012

• REC opinion

  Further Information Favourable Opinion