Pain
Conditions
Keywords
Malignant pain, Nonmalignant pain, Pain, Pediatric, Opioid, Moderate to severe
Brief 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.
Interventions
DRUGOxycodone hydrochloride controlled-release tablets
Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.
Sponsors
Purdue Pharma LP
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Adverse Events as a Measure of Safety. | Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment). | Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale \[UMSS\]). Safety variables were summarized descriptively within age group for the extension safety population. |
Countries
Israel, United States
Participant flow
Recruitment details
First Patient First Visit: 05-January-2012; Last Patient Last Visit: 09-December-2013. The study was conducted at 14 medical/research sites in the United States and Israel.
Pre-assignment details
Opioid-experienced pediatric patients with moderate to severe malignant and/or nonmalignant pain requiring around-the-clock opioid therapy were eligible for open-label Extension Study OTR3002 if they completed the 4-week treatment period Core Study OTR3001 and could benefit from continued treatment with oxycodone HCl CR 20 to 240 mg total daily.
Participants by arm
| Arm | Count |
|---|---|
| 6 to < 12 Years Children 6 to \< 12 years of age | 9 |
| ≥ 12 to ≤ 16 Years Children 12 to ≤ 16 years of age | 14 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 6 to < 12 Years | ≥ 12 to ≤ 16 Years | Total |
|---|---|---|---|
| Age, Continuous | 9.9 years STANDARD_DEVIATION 1.76 | 14.3 years STANDARD_DEVIATION 1.49 | 12.6 years STANDARD_DEVIATION 2.69 |
| Race/Ethnicity, Customized Black or African American | 3 participants | 4 participants | 7 participants |
| Race/Ethnicity, Customized White | 6 participants | 10 participants | 16 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 9 | 8 / 14 |
| serious Total, serious adverse events | 3 / 9 | 2 / 14 |
Outcome results
Primary
The Number of Participants With Adverse Events as a Measure of Safety.
Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale \[UMSS\]). Safety variables were summarized descriptively within age group for the extension safety population.
Time frame: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).
Population: The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 to < 12 Years | The Number of Participants With Adverse Events as a Measure of Safety. | Serious adverse events | 3 participants |
| 6 to < 12 Years | The Number of Participants With Adverse Events as a Measure of Safety. | All other adverse events in ≥ 5% of patients | 8 participants |
| ≥ 12 to ≤ 16 Years | The Number of Participants With Adverse Events as a Measure of Safety. | Serious adverse events | 2 participants |
| ≥ 12 to ≤ 16 Years | The Number of Participants With Adverse Events as a Measure of Safety. | All other adverse events in ≥ 5% of patients | 8 participants |