Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
Condition: Pain
Intervention: Oxycodone hydrochloride controlled-release tablets
Intervention description: Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.
Intervention MeSH terms: Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Malignant pain; Nonmalignant pain; Pain; Pediatric; Opioid; Moderate to severe

Summary:

      The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride
      (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17
      years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid
      therapy who completed the 4 -week treatment period in OTR3001.
    

Eligibility criteria:

        Inclusion Criteria include:

          1. Male and female patients 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;

          3. Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.

        Exclusion Criteria include:

          1. Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion,
             disqualify them from participation in the study;

          2. Female patients who are pregnant or lactating;

          3. Patients requiring opioid at doses equivalent to < 20 mg/day or > 240 mg/day oxycodone
             for treatment of their malignant or nonmalignant pain;

          4. Patients who are allergic to oxycodone or have a history of allergies to other opioids
             (this criterion does not include patients who have experienced common opioid side
             effects [eg, nausea, constipation]);

          5. Patients who are contraindicated for the use of opioids;

          6. Patients who are currently being maintained on methadone for pain;

          7. Patients who have an abnormality on vital signs, physical examination, or laboratory
             testing significant enough that the investigator deems the patient is not appropriate
             for the study;

          8. Patients who have any planned surgery during the course of the study, with the
             exception of the placement of central or peripheral venous access devices;

          9. Patients currently taking an investigational medication/therapy other than the study
             drug (oxycodone HCl CR) at the start of screening or during the study.

        Other protocol specific inclusion/exclusion criteria may apply.