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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

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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: Oxycodone HCl controlled-release tablets
Enrollment 155
Recruitment Details First Patient First Visit: 28-Feb-2011; Last Patient Last Visit: 29-Jul-2014. The study was conducted at medical/research sites in the United States, Spain, United Kingdom, Greece, Guatemala, Hungary, Israel, and New Zealand
Pre-assignment Details  
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description Children 6 to < 12 years of age Children ≥ 12 to ≤ 16 years of age
Period Title: Overall Study
Started 27 128
Completed 17 105
Not Completed 10 23
Reason Not Completed
Adverse Event             3             7
Withdrawal by Subject             3             4
Lost to Follow-up             0             1
Lack of Efficacy             0             5
Administrative             4             6
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years Total
Hide Arm/Group Description Children 6 to < 12 years of age Children ≥ 12 to ≤ 16 years of age Total of all reporting groups
Overall Number of Baseline Participants 27 128 155
Hide Baseline Analysis Population Description
The safety population was the group of patients who received at least 1 dose of study drug during the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 128 participants 155 participants
9.6  (1.65) 14.5  (1.34) 13.7  (2.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 128 participants 155 participants
Female
14
  51.9%
75
  58.6%
89
  57.4%
Male
13
  48.1%
53
  41.4%
66
  42.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 27 participants 128 participants 155 participants
White 20 88 108
Black or African American 7 31 38
Asian 0 1 1
Other 0 8 8
1.Primary Outcome
Title The Number of Participants With Adverse Events as a Measure of Safety.
Hide Description 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.
Time Frame Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was the group of patients who received at least 1 dose of study drug during the study.
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description:
Children 6 to < 12 years of age
Children ≥ 12 to ≤ 16 years of age
Overall Number of Participants Analyzed 27 128
Measure Type: Number
Unit of Measure: participants
Serious adverse events 5 22
All other adverse events in ≥ 5% of patients 13 60
2.Secondary Outcome
Title Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Hide Description 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.
Time Frame Baseline to week 4
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Hide Analysis Population Description
The safety population was the group of patients who received at least 1 dose of study drug during the study.
Arm/Group Title 6 to < 12 Years
Hide Arm/Group Description:
Children 6 to < 12 years of age
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: number (n)=27 4.44  (3.250)
Average during week 1: morning;n=25 4.11  (2.674)
Average during week 1: evening; n=26 4.07  (2.695)
Average during week 2: morning; n=23 3.66  (2.640)
Average during week 2: evening; n=22 3.70  (2.686)
Average during week 3: morning; n=17 3.64  (2.579)
Average during week 3: evening; n=17 3.76  (2.669)
Average during week 4: morning; n=14 3.13  (2.569)
Average during week 4: evening; n=14 3.42  (2.974)
3.Secondary Outcome
Title Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Hide Description 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.
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was the group of patients who received at least 1 dose of study drug during the study.
Arm/Group Title ≥ 12 to ≤ 16 Years
Hide Arm/Group Description:
Children ≥ 12 to ≤ 16 years of age
Overall Number of Participants Analyzed 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: n=126 44.58  (28.291)
Average during week 1: morning; n=124 40.38  (24.402)
Average during week 1: evening; n=124 39.24  (23.301)
Average during week 2: morning; n=122 34.49  (24.980)
Average during week 2: evening; n=122 33.04  (24.778)
Average during week 3: morning; n=101 32.56  (25.802)
Average during week 3: evening; n=88 33.46  (24.639)
Average during week 4: morning; n=53 35.58  (27.177)
Average during week 4: evening; n=50 35.30  (26.711)
4.Secondary Outcome
Title Use of Supplemental Pain Medication
Hide Description 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.
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was the group of patients who received at least 1 dose of study drug during the study.
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description:
Children 6 to < 12 years of age
Children ≥ 12 to ≤ 16 years of age
Overall Number of Participants Analyzed 27 128
Measure Type: Number
Unit of Measure: participants
Any supplemental pain medication 24 112
Any opioid supplemental pain medication 21 93
Any nonopioid supplemental pain medication 17 75
5.Secondary Outcome
Title Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
Hide Description 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.
Time Frame Baseline to week 4 or early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was the group of patients who received at least 1 dose of study drug during the study.
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description:
Children 6 to < 12 years of age
Children ≥ 12 to ≤ 16 years of age
Overall Number of Participants Analyzed 25 115
Measure Type: Number
Unit of Measure: participants
1 = Very much improved 10 42
2 = Much improved 8 51
3 = Minimally improved 3 15
4 = No change 3 5
5 = Minimally worse 0 1
6 = Much worse 0 0
7 = Very much worse 1 1
6.Secondary Outcome
Title Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years
Hide Description 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.
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was the group of patients who received at least 1 dose of study drug during the study.
Arm/Group Title 6 to < 12 Years
Hide Arm/Group Description:
Children 6 to < 12 years of age
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: n =26 27.1  (13.06)
Week 4: n=25 23.0  (13.32)
7.Secondary Outcome
Title Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years
Hide Description 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.
Time Frame Baseline to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was the group of patients who received at least 1 dose of study drug during the study.
Arm/Group Title ≥ 12 to ≤ 16 Years
Hide Arm/Group Description:
Children ≥ 12 to ≤ 16 years of age
Overall Number of Participants Analyzed 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: n=127 23.2  (17.47)
Week 4: n=119 20.4  (12.65)
8.Secondary Outcome
Title Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Hide Description 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.
Time Frame Day 1, week 2, and week 4
Outcome Measure Data Not Reported
Time Frame Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
Adverse Event Reporting Description AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
 
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description Children 6 to < 12 years of age Children ≥ 12 to ≤ 16 years of age
All-Cause Mortality
6 to < 12 Years ≥ 12 to ≤ 16 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
6 to < 12 Years ≥ 12 to ≤ 16 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   5/27 (18.52%)   22/128 (17.19%) 
Blood and lymphatic system disorders     
Febrile neutropenia † 1  1/27 (3.70%)  4/128 (3.13%) 
Neutropenia † 1  2/27 (7.41%)  1/128 (0.78%) 
Cardiac disorders     
Cardio-respiratory arrest † 1 [1]  1/27 (3.70%)  0/128 (0.00%) 
Congenital, familial and genetic disorders     
Sickle cell anaemia with crisis † 1  0/27 (0.00%)  1/128 (0.78%) 
Ear and labyrinth disorders     
Vertigo † 1  0/27 (0.00%)  1/128 (0.78%) 
Eye disorders     
Diplopia † 1  0/27 (0.00%)  1/128 (0.78%) 
Gastrointestinal disorders     
Abdominal pain † 1  0/27 (0.00%)  1/128 (0.78%) 
Diarrhoea † 1  0/27 (0.00%)  1/128 (0.78%) 
Pancreatitis acute † 1  0/27 (0.00%)  1/128 (0.78%) 
Stomatitis † 1  1/27 (3.70%)  0/128 (0.00%) 
Vomiting † 1  0/27 (0.00%)  2/128 (1.56%) 
General disorders     
Pain † 1  0/27 (0.00%)  2/128 (1.56%) 
Pyrexia † 1  2/27 (7.41%)  5/128 (3.91%) 
Infections and infestations     
Gangrene † 1  0/27 (0.00%)  1/128 (0.78%) 
Gastroenteritis clostridial † 1  0/27 (0.00%)  1/128 (0.78%) 
Osteomyelitis † 1  0/27 (0.00%)  1/128 (0.78%) 
Post procedural cellulitis † 1  0/27 (0.00%)  1/128 (0.78%) 
Injury, poisoning and procedural complications     
Fall † 1  0/27 (0.00%)  1/128 (0.78%) 
Post procedural complication † 1  0/27 (0.00%)  1/128 (0.78%) 
Procedural pain † 1  0/27 (0.00%)  1/128 (0.78%) 
Seroma † 1  0/27 (0.00%)  2/128 (1.56%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  1/27 (3.70%)  0/128 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression † 1 [1]  0/27 (0.00%)  1/128 (0.78%) 
Nervous system disorders     
Balance disorder † 1  0/27 (0.00%)  1/128 (0.78%) 
Coma † 1 [2]  1/27 (3.70%)  1/128 (0.78%) 
Convulsion † 1 [3]  1/27 (3.70%)  0/128 (0.00%) 
Dizziness † 1  0/27 (0.00%)  1/128 (0.78%) 
Headache † 1  0/27 (0.00%)  2/128 (1.56%) 
Lethargy † 1  0/27 (0.00%)  1/128 (0.78%) 
Status migrainosus † 1  0/27 (0.00%)  1/128 (0.78%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis † 1  0/27 (0.00%)  1/128 (0.78%) 
Hypoxia † 1 [4]  0/27 (0.00%)  1/128 (0.78%) 
Respiratory disorder † 1 [5]  1/27 (3.70%)  0/128 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash † 1  0/27 (0.00%)  1/128 (0.78%) 
Vascular disorders     
Axillary vein thrombosis † 1  0/27 (0.00%)  1/128 (0.78%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
[1]
Outcome: Death
[2]
Outcome: Death. 1 patient (6 to < 12 Years) experienced 3 serious AEs resulting in death: coma, convulsion, and respiratory disorder; 1 patient (≥ 12 to ≤ 16 Years) experienced 2 serious AEs resulting in death: coma and hypoxia.
[3]
Outcome: Death. 1 patient (6 to < 12 Years) experienced 3 serious AEs resulting in death: coma, convulsion, and respiratory disorder.
[4]
Outcome: death. 1 patient (≥ 12 to ≤ 16 Years) experienced 2 serious AEs resulting in death: coma and hypoxia.
[5]
1 patient (6 to < 12 Years) experienced 3 serious AEs resulting in death: coma, convulsion, and respiratory disorder.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
6 to < 12 Years ≥ 12 to ≤ 16 Years
Affected / at Risk (%) Affected / at Risk (%)
Total   13/27 (48.15%)   60/128 (46.88%) 
Gastrointestinal disorders     
Vomiting † 1  6/27 (22.22%)  26/128 (20.31%) 
Nausea † 1  3/27 (11.11%)  20/128 (15.63%) 
Constipation † 1  4/27 (14.81%)  12/128 (9.38%) 
General disorders     
Pyrexia † 1  5/27 (18.52%)  8/128 (6.25%) 
Nervous system disorders     
Headache † 1  3/27 (11.11%)  17/128 (13.28%) 
Dizziness † 1  0/27 (0.00%)  11/128 (8.59%) 
Skin and subcutaneous tissue disorders     
Pruritus † 1  3/27 (11.11%)  7/128 (5.47%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Purdue Pharma L.P.
Phone: 800-733-1333
Layout table for additonal information
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01192295     History of Changes
Other Study ID Numbers: OTR3001
2010-020471-23 ( EudraCT Number )
First Submitted: August 30, 2010
First Posted: September 1, 2010
Results First Submitted: January 22, 2015
Results First Posted: February 6, 2015
Last Update Posted: October 18, 2017