Offered by: Nemours
Location: Delaware Valley
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.
Contact Nemours Clinical Trials
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