Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
Information source: Purdue Pharma LP
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Oxycodone hydrochloride controlled-release tablets (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Purdue Pharma LP
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.
Clinical Details
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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Number of Participants With Adverse Events as a Measure of Safety.
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
Schneider Children Medical Center of Israel, Petach Tikva 49202, Israel
Children's Hospital of Alabama, Birmingham, Alabama 35233, United States
Bayview Research Group, LLC, Paramount, California 90723, United States
Children's Hospital Colorado, Aurora, Colorado 80045, United States
Jackson Memorial Hospital, Miami, Florida 33136, United States
University of Kentucky, Lexington, Kentucky 40536, United States
Mercy Clinic Children's Cancer and Hematology Center, St. Louis, Missouri 63141, United States
New York University Langone Medical Center, New York, New York 10016, United States
Stony Brook University Hospital, Stony Brook, New York 11794, United States
Presbyterian Blume Pediatric Hematology & Oncology Clinic, Charlotte, North Carolina 28204, United States
Akron Children's Hospital, Akron, Ohio 44308, United States
The Children's Hospital at Oklahoma University Medical Center, Oklahoma City, Oklahoma 73104, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee 37232, United States
Children's Medical Center of Dallas, Dallas, Texas 75235, United States
Additional Information
Product Information
Starting date: October 2011
Last updated: January 7, 2015
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