Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-Release Tablets

Trial Name

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

What is the trial about?

This is a study to investigate the safety, effectiveness, and dosage of oxycodone hydrochloride controlled-release tablets in pediatric patients aged 6 to 16 years, with moderate to severe pain requiring opioid therapy.

Who can participate?

This study is open to children who: are 6-16 years old are expected to need around-the-clock opioid medication for moderate to severe pain for at least the next 2 weeks, have taken opioids for at least the 5 days before dosing at Visit 1 have taken the equivalent of at least 20mg of oxycodone daily over the last 48 hours before dosing at Visit 1 are able to swallow pills without chewing or crushing them.

What is involved?

Your child’s participation will last about 5-6 weeks. This includes a screening period of up to 3 days, a treatment period of at least 2 weeks and up to 4 weeks, and a follow-up period of 7 to 10 days. There will be at least 2 office visits. You will also receive a phone call at least every 48 hours while your child is taking the study drug. The phone calls should last approximately 15 minutes.

Your child will have his/her blood drawn once or twice at each visit. The medication will be given twice a day every day. You and your child will be required to complete a study diary entry for each dose of medication. You will also receive phone calls from the study team every other day to see how your child is doing.