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Trial record 28 of 666 for:    OXYCODONE

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

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ClinicalTrials.gov Identifier: NCT01192295
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : February 6, 2015
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Tracking Information
First Submitted Date  ICMJE August 30, 2010
First Posted Date  ICMJE September 1, 2010
Results First Submitted Date  ICMJE January 22, 2015
Results First Posted Date  ICMJE February 6, 2015
Last Update Posted Date October 18, 2017
Study Start Date  ICMJE November 2010
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
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). ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2010)
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). ]
Change History Complete list of historical versions of study NCT01192295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
  • Pain Right Now Assessment by Patients Aged 6 to < 12 Years [ Time Frame: Baseline to week 4 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Oxycodone HCl controlled-release
Oxycodone hydrochloride (HCl) controlled-release (CR)
Intervention: Drug: Oxycodone HCl controlled-release tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2014)
155
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2010)
100
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece,   Hungary,   Israel,   New Zealand,   Romania,   Spain,   United Kingdom,   United States
Removed Location Countries Belgium,   Estonia,   Finland,   Germany,   Guatemala,   Poland,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT01192295
Other Study ID Numbers  ICMJE OTR3001
2010-020471-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Purdue Pharma LP
Study Sponsor  ICMJE Purdue Pharma LP
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Purdue Pharma LP
Verification Date September 2017

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