Clinical Trials for Children - OxyContin

This study is currently recruiting participants.

Verified April 2012 by Purdue Pharma LP

First Received on August 30, 2010. Last Updated on April 3, 2012 History of Changes

Sponsor:	Purdue Pharma LP
Information provided by (Responsible Party):	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT01192295

Purpose

The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.

Condition	Intervention	Phase
Pain	Drug: Oxycodone HCl controlled-release tablets	Phase III

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, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children From Ages 6 to 16 Years Old, Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics

Resource links provided by NLM:

Drug Information available for: OxycodoneOxycodone hydrochloride

U.S. FDA Resources

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 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment). ] [ Designated as safety issue: Yes ]
  

Secondary Outcome Measures:

• To characterize the efficacy and provide additional pharmacokinetics (PK) data of oxycodone hydrochloride controlled-release tablets [ Time Frame: 2-4 and 4-6 hours (hrs) after the first dose on Day 1 and immediately pre-dose and 2-4 hrs after dose at Visit 2 and/or Visit 3. ] [ Designated as safety issue: No ]
  To characterize the efficacy and provide additional pharmacokinetics (PK) data for a population PK model of oxycodone hydrochloride controlled-release tablets in opioid tolerant pediatric patients aged 6 to16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
  
  

Estimated Enrollment:	154
Study Start Date:	November 2010
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Oxycodone HCl controlled-release Oxycodone hydrochloride (HCl) controlled-release (CR)	Drug: Oxycodone HCl controlled-release tablets Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours. Other Name: OxyContin

Eligibility

Ages Eligible for Study:	6 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria include:

• Male and female patients aged 6 to 16 years, inclusive, who are expected to require ongoing around-the-clock opioid treatment equivalent to at least 20-mg daily dose of oxycodone for at least 2 weeks for management of moderate to severe (based on the investigator's judgment) malignant or nonmalignant pain.
• Patients must be opioid tolerant, ie, have been treated with opioids for at least the 5 consecutive days prior to dosing and with at least 20 mg daily of oxycodone or the equivalent during at least the last 48 hours prior to the start of study drug dosing and have tolerated the therapy, as demonstrated at the start of study drug dosing.
• Patients who are currently using transdermal fentanyl should have been on the patch for at least 3 days before removing the patch and oxycodone hydrochloride (HCl) controlled-release (CR) treatment can only be initiated at least 18 hours following the removal of the transdermal fentanyl patch.
• Patients must not require more than a 240-mg total daily dose of oxycodone HCl CR tablets.
• Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.
• Patients must not be currently on an investigational medication/therapy at the start of screening or during the study.

Exclusion Criteria include:

• Female patients who are pregnant or lactating.
• 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]).
• Patients who have received epidural opioids < 2 hours prior to the first dose of study drug or who have received epidural morphine < 12 hours prior to the first dose of study drug.
• Patients who are contraindicated for the use of opioids.
• Patients who are contraindicated for blood sampling.
• Patients who are currently being maintained on methadone for pain.
• 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.
• Patients who have had surgery within 5 days prior to Day 1 (day of first dose of study drug).
• Patients who, in the investigator's opinion, have an underlying gastrointestinal condition or other disorder that may predispose them to obstruction.

Other protocol-specific inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192295

Contacts

Contact: Deborah Steiner, MD

203-588-7413

deborah.steiner@pharma.com

Show 98 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

More Information

Additional Information:

Product Information

No publications provided

Responsible Party:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT01192295 History of Changes
Other Study ID Numbers:	OTR3001, 2010-020471-23
Study First Received:	August 30, 2010
Last Updated:	April 3, 2012
Health Authority:	United States: Food and Drug Administration Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency Israel: Ministry of Health New Zealand: Medsafe Greece: National Organization of Medicines Hungary: National Institute of Pharmacy Poland: Ministry of Health Belgium: Federal Agency for Medicinal Products and Health Products Romania: Ministry of Public Health Guatemala: Ministry of Public Health and Social Assistance Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Purdue Pharma LP:

Malignant pain Nonmalignant pain Pediatric Opioid Moderate to severe malignant or nonmalignant pain

Additional relevant MeSH terms:

Analgesics, Opioid Oxycodone Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs

Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics

ClinicalTrials.gov processed this record on April 12, 2012

_________________________________

Salem-News.com Investigative Reporter Marianne Skolek, is an Activist for Victims of OxyContin and Purdue Pharma throughout the United States and Canada. In July 2007, she testified against Purdue Pharma in Federal Court in Virginia at the sentencing of their three CEO's - Michael Friedman, Howard Udell and Paul Goldenheim - who pleaded guilty to charges of marketing OxyContin as less likely to be addictive or abused to physicians and patients. She also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne works with government agencies and private attorneys in having a voice for her daughter Jill, who died in 2002 after being prescribed OxyContin, as well as the voice for scores of victims of OxyContin. She has been involved in her work for the past 8-1/2 years and is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin.

Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.

Marianne Skolek
Investigative Reporter for Salem-News.com
Victims of OxyContin and Purdue Pharma - a criminally convicted pharmaceutical company
http://www.salem-news.com/by_author.php?reporter=Marianne%20Skolek
http://judiciary.senate.gov/hearings/testimony.cfm?id=e655f9e2809e5476862f735da12c8394&wit_id=e655f9e2809e5476862f735da12c8394-2-1
http://www.vawd.uscourts.gov/PurdueFrederickCo/default.asp
www.oxydeaths.com
908-285-1232

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Mike Sprague April 19, 2012 8:58 am (Pacific time)

How this company continues in it's efforts to harm the country and now the youth of the country is beyond me Marianne. It sickens me.... they need to say the Purpose of the study is to make many more billions. This is unacceptable.

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