Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids - Full Text View

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 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, 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: Oxycodone Oxycodone 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:	August 2013
Estimated Primary Completion Date:	August 2013 (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 99 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

More Information

Additional Information:

Product Information This link exits the ClinicalTrials.gov site

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:	May 7, 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 May 23, 2012