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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

Page last updated: August 23, 2015

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