SIU School of Medicine

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Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids

IRB Number

12-149

ClinicalTrials.gov Identifier

NCT01192295

Trial Status

Open for Enrollment
Phase 1

Why is this study being done?

To test the safety, side effects and effectiveness of oxycodone HCl CR in children.

Who is eligible to participate?

Children ages 6 to 16 that are expected to need around-the-clock opioid medication for moderate to severe pain for at least 2 weeks.

What is involved?

Participants will have a physical examination, will be asked to complete questionnaires, and urine and blood samples will be taken. Participants will be asked to complete diaries. The study medication will be given twice daily for the duration of the study.

How long is the study?

Participation will last about 5-6 weeks. This includes a screening period of up to 2 days, a treatment period of at least 2 weeks and up to 4 weeks, and a follow-up period of 7 to 10 days.

Who can I contact for additional information?

Please contact Kristal Adams, BA, CCRP, at (217) 545-7812 or email kadams@siumed.edu

Who is the Principal Investigator of this study?

Gregory Brandt, MD

Where is the trial located?

Springfield, Illinois