Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001

Purdue Pharma

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Oxycodone hydrochloride controlled-release tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01369615

OTR3002

2011-002235-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Oxycodone HCl controlled-release

Experimental group

Description:

Oxycodone hydrochloride controlled-release tablets

Treatment:

Drug: Oxycodone hydrochloride controlled-release tablets