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

Study ID
STU 072011-009

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Roxana Ploski
214-456-8559
roxana.ploski@utsouthwestern.edu

Principal Investigator
Peter Szmuk

Summary

This is an open-label extension study to assess the long-term safety of oxycodone HCl CR
tablets, 20 mg to 240 mg total daily, in opioid experienced pediatric patients 6 to 17 years of
age, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid
therapy. The maximum duration of the treatment period is 6 months and only patients who
completed the 4-week treatment period OTR3001 study are eligible to participate in OTR3002.
The first day (visit 1) of this study will occur on the same day as visit 3 in OTR3001. Clinical
laboratory test results from visit 3 in OTR3001 will be used to establish patient eligibility for this
study. Patients may begin treatment with oxycodone HCl CR at visit 1 prior to the receipt of the
laboratory test results. However, if upon investigator receipt and review of the laboratory test
results from visit 3 of OTR3001, a patient fails to meet the eligibility criteria for OTR3002, that
patient will be instructed to discontinue study drug treatment and return to the study site to
complete all early discontinuation visit procedures.
At visit 1, patients may continue on the oxycodone HCl CR doses they received at the end of
the OTR3001, or have their doses adjusted according the clinical judgment of the investigator.
All subsequent visits will occur at weeks 4, 8, 12, 16, 20, and 24 (visit 2 to visit 7). At each
scheduled visit, information regarding adverse events, concomitant medication, supplemental
pain medication, vital signs, urine, and study medication changes will be recorded. A urine
pregnancy test will be performed for all applicable patients at visits 2 to 6, and a serum
pregnancy test will be performed at visit 7 for these patients. A physical exam and laboratory
evaluations will be performed at visits 2 and 4 (weeks 4 and 12) and at the final study visit (visit
7/week 24). Additional visits may occur at the discretion of the investigator for interim safety or
tolerability assessments (including any additional laboratory assessments), study drug resupply,
or study drug dose adjustment.
Unlimited dose adjustments (between oxycodone HCl CR 20 mg total daily dose and oxycodone
HCl CR 240 mg total daily dose) are permitted as necessary throughout the study based on the
clinical judgment of the investigator. The maximum dose for a single uptitration should not
exceed 25% of the patient[Single Quote]s current dose. The parent/caregiver must contact the investigator
prior to each dose adjustment, and the dose adjustments may take place during a scheduled
visit, as an unscheduled visit at the study site, or away from the site based on investigator
judgment. Study drug dose downtitration may take place at any time; dose uptitration is
permitted anytime after a minimum 48 hour-treatment duration on the same dose.
Supplemental opioid and nonopioid analgesic medications, including any oxycodone-containing
products, are permitted during the study at the discretion of the investigator.
A patient may discontinue drug at any time during the study. In the event the patient
discontinues from the study, the patient must return to the clinic site for visit 7/early
discontinuation visit. The reason for study drug discontinuation must be recorded.
All patients will have a follow-up phone call or visit 7 to 10 days after their last dose of
oxycodone HCl CR for a safety follow-up evaluation.

Participant Eligibility

1) Male and female patient aged 6 to 17 years, inclusive, who completed the 4-week study
drug treatment in study OTR3001 and who, based on the investigator's judgment, will
benefit from continuing treatment with oxycodone HCL CR 20 to 240 mg/day for the
management of moderate to severe malignant or nonmalignant pain;

2) Patients must have tolerated the oxycodone HCL CR therapy in OTR3001 as demonstrated
at the start of the study by:
A normal respiratory rate for age;
No significant (grade 3 or 4) opioid-induced somnolence at visit 1 based on the
University of Michigan Sedation Scale (UMSS) and the investigator[?]s judgment;
The clinical judgment of the investigator;

3) Patients must be willing and able to swallow the oxycodone HCl CR tablets whole;

4) Female patients of childbearing age must have a negative pregnancy test at visit 3 of
OTR3001 and must be nonlactating;

5) Patients must have a parent/caregiver who can perform all study assessments, including the
UMSS assessment, and record the doses of oxycodone HCl CR tablets, and doses of
supplemental pain medication;

6) Female patients who are sexually active must be using an acceptable method of birth
control;

7) Patients and parents/caregivers who are willing and able to be compliant with the protocol,
are capable of patient evaluation, are willing and able to use a diary, and are able to read,
understand, and sign the written informed consent and/or assent.