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

This study is currently recruiting participants.
Verified March 2013 by Purdue Pharma LP
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01192295
First received: August 30, 2010
Last updated: March 20, 2013
Last verified: March 2013
History of Changes

August 30, 2010
March 20, 2013
November 2010
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01192295 on ClinicalTrials.gov Archive Site
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 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
Not Provided
Not Provided
Not Provided
 
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
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

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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
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
Experimental: Oxycodone HCl controlled-release
Oxycodone hydrochloride (HCl) controlled-release (CR)
Intervention: Drug: Oxycodone HCl controlled-release tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
6 Years to 16 Years
No
Contact: Eduardo Rodenas, MD 203-588-7660 Eduardo.Rodenas@pharma.com
United States,   Belgium,   Estonia,   Finland,   Germany,   Greece,   Guatemala,   Hungary,   Israel,   New Zealand,   Poland,   Romania,   Spain,   Sweden,   United Kingdom
 
NCT01192295
OTR3001, 2010-020471-23
Yes
Purdue Pharma LP
Purdue Pharma LP
Not Provided
Not Provided
Purdue Pharma LP
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP