Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
- Registration Number
- NCT01192295
- Lead Sponsor
- Purdue Pharma LP
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oxycodone HCl controlled-release Oxycodone HCl controlled-release tablets Oxycodone hydrochloride (HCl) controlled-release (CR)
- Primary Outcome Measures
Name Time Method The Number of Participants With Adverse Events as a Measure of Safety. 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.
- Secondary Outcome Measures
Name Time Method Pain Right Now Assessment by Patients Aged 6 to < 12 Years 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.
Use of Supplemental Pain Medication 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 Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years 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 to Maximum Concentration (Tmax) Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose.
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years 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.
Parent/ Caregiver-Assessed Global Impression of Change (PGIC) 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 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 Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. Cmax was taken as the maximum simulated oxycodone concentration over the dosing interval and Cmin was the simulated oxycodone concentration when time was equal to 12 hours. Steady-state Cmin and Cmax were derived from the accumulation ratio.
The following PK parameters are presented: Cmin / Cmax (minimum / maximum concentration); Cmin,ss / Cmax,ss (Cmin / Cmax at steady state); CAVGss (average concentration at steady state).Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. First-dose area under the concentration-time curve (AUC) was derived from the accumulation ratio. For all calculations, the dosing interval was assumed to be 12 hours.
The following PK parameters are presented: AUCtau (area under the concentration-time curve from time zero to time equal to dosing interval); AUCss (AUC at steady state).Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. The accumulation ratio is used to derive steady-state Cmin and Cmax and first-dose area under the concentration-time curve (AUCtau).
Trial Locations
- Locations (47)
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Research Facility
🇺🇸The Woodlands, Texas, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of South Alabama, Children's and Women's Hospital
🇺🇸Mobile, Alabama, United States
LS Packard Children's Hospital
🇺🇸Palo Alto, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Spitalul Clinic Judetean de Urgenta Targu Mures, Clinica pediatrie I
🇷🇴Targu Mures, Romania
Agia Sophia Children's Hospital
🇬🇷Athens, Greece
Aglaia Kyriakou - Elpida Children's Oncology Unit
🇬🇷Athens, Greece
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
Schneider Children Medical Center of Israel
🇮🇱Petaẖ Tiqwa, Israel
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
🇭🇺Budapest, Hungary
Starship Children's Health
🇳🇿Grafton, Auckland, New Zealand
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Helen DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
St. John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Children's Medical Ctr of Dallas
🇺🇸Dallas, Texas, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Pediatric Hematology and Oncology, Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
Hadassah Medical Organization, Ein Kerem
🇮🇱Jerusalem, Israel
Mayer Children Hospital, Rambam Medical Center
🇮🇱Haifa, Israel
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom
Bayview Research Group, LLC
🇺🇸Paramount, California, United States
Soroka University Medical Center
🇮🇱Beersheba, Israel
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Shriners Hospitals for Children Northern California
🇺🇸Sacramento, California, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
The Children's Hospital
🇺🇸Aurora, Colorado, United States
Jackson Memorial Hospital/University of Miami
🇺🇸Miami, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Department of Pediatrics, University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
The Children's Hospital at OUMC
🇺🇸Oklahoma City, Oklahoma, United States
Legacy Emanuel Children's Hospital
🇺🇸Portland, Oregon, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Presbyterian Blume Pediatric Hematology and Oncology Clinic
🇺🇸Charlotte, North Carolina, United States