Clinical trial NCT01369615: Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Malignant pain
Nonmalignant pain
Pain
Pediatric
Opioid
Moderate to severe
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Number of Participants With Adverse Events as a Measure of Safety.
timeFrame: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Paramount
country: United States
facility: Bayview Research Group, LLC
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: St. Louis
country: United States
facility: Mercy Clinic Children's Cancer and Hematology Center
state: Missouri
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Charlotte
country: United States
facility: Presbyterian Blume Pediatric Hematology & Oncology Clinic
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: The Children's Hospital at Oklahoma University Medical Center
state: Oklahoma
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Petach Tikva
country: Israel
facility: Schneider Children Medical Center of Israel
Study officials:
References: