Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
Status: | Completed |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 6 - 17 |
Updated: | 4/21/2016 |
Start Date: | October 2011 |
End Date: | May 2014 |
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
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.
(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.
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.
We found this trial at
14
sites
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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Children's Hospital of Alabama Children
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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