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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01369615
First received: June 7, 2011
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Oxycodone hydrochloride controlled-release tablets
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • The number of participants with adverse events as a measure of safety. [ Time Frame: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment). ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxycodone HCl controlled-release
Oxycodone hydrochloride controlled-release tablets
Drug: Oxycodone hydrochloride controlled-release tablets
Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.
Other Name: OxyContin

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369615

Locations
United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, California
Bayview Research Group, LLC
Paramount, California, United States, 90723
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Missouri
Mercy Clinic Children's Cancer and Hematology Center
St. Louis, Missouri, United States, 63141
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, North Carolina
Presbyterian Blume Pediatric Hematology & Oncology Clinic
Charlotte, North Carolina, United States, 28204
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
United States, Oklahoma
The Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Israel
Schneider Children Medical Center of Israel
Petach Tikva, Israel, 49202
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional Information:
No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01369615     History of Changes
Other Study ID Numbers: OTR3002, 2011-002235-26
Study First Received: June 7, 2011
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by Purdue Pharma LP:
Malignant pain
Nonmalignant pain
Pain
Pediatric
Opioid
Moderate to severe

Additional relevant MeSH terms:
Oxycodone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014