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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01192295
First received: August 30, 2010
Last updated: March 16, 2015
Last verified: March 2015
  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:


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: No ]
    Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.


Secondary Outcome Measures:
  • Pain Right Now Assessment by Patients Aged 6 to < 12 Years [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with "no hurt" at the far left and "hurts worst" at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.

  • Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked "no pain" and the opposite end marked as "pain as bad as it could be." The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the "no pain" end to the patient's mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.

  • Use of Supplemental Pain Medication [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight.

  • Parent/ Caregiver-Assessed Global Impression of Change (PGIC) [ Time Frame: Baseline to week 4 or early discontinuation ] [ Designated as safety issue: No ]
    The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group.

  • Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.

  • Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.

  • Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets [ Time Frame: Day 1, week 2, and week 4 ] [ Designated as safety issue: No ]
    Plasma concentration data were characterized for a population PK model of oxycodone hydrochloride controlled-release tablets in opioid tolerant pediatric patients. Plasma samples were collected after the first dose on day 1 (one sample 2 to 4 hours after the dose and 1 sample 4 to 6 hours after the dose with approximately 2 hours between the samples), and immediately predose (morning or evening dose) and 2 to 4 hours after that dose at visit 2 and/or visit 3; a total of 4 to 6 samples were collected.


Enrollment: 155
Study Start Date: November 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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
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: NCT01192295

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Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional 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
Results First Received: January 22, 2015
Last Updated: March 16, 2015
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:
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 August 03, 2015