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Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT01160614
Recruitment Status : Completed
First Posted : July 12, 2010
Results First Posted : August 21, 2012
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Opioid Analgesia
Intervention Drug: Oxycodone hydrochloride controlled-release (ORF) tablets
Enrollment 30
Recruitment Details First Patient First Visit: 18-Aug-2010; Last Patient Last Visit: 16-Aug-2011. The study was conducted at 11 sites in the United States and Australia.
Pre-assignment Details Pediatric patients who were anticipated to have pain requiring opioid analgesia.
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses). Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
Period Title: Overall Study
Started 5 25
Completed 5 23
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years Total
Hide Arm/Group Description Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses). Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses). Total of all reporting groups
Overall Number of Baseline Participants 5 25 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 25 participants 30 participants
10.6  (0.9) 14.1  (1.6) 13.5  (2.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 25 participants 30 participants
Female
3
  60.0%
14
  56.0%
17
  56.7%
Male
2
  40.0%
11
  44.0%
13
  43.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 25 participants 30 participants
American Indian or Alaska Native
0
   0.0%
1
   4.0%
1
   3.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  20.0%
3
  12.0%
4
  13.3%
White
4
  80.0%
21
  84.0%
25
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]
Hide Description [Not Specified]
Time Frame Up to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric
Arm/Group Title 6 to < 12 Years (10 mg ORF) 6 to < 12 Years (15 mg ORF) 6 to < 12 Years (20 mg ORF) ≥ 12 to ≤ 16 Years (10 mg ORF) ≥ 12 to ≤ 16 Years (15 mg ORF) ≥ 12 to ≤ 16 Years (20 mg ORF)
Hide Arm/Group Description:
Children from 6 to < 12 years received a single dose of 10 mg ORF
Children from 6 to < 12 years received a single dose of 15 mg ORF
Children from 6 to < 12 years received a single dose of 20 mg ORF
Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
Overall Number of Participants Analyzed 1 1 1 2 5 8
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
129.2 [1]   (NA) 121.1 [1]   (NA) 272.2 [1]   (NA) 85.5  (39.3) 193.0  (149.4) 264.4  (128.1)
[1]
Standard deviation not calculable since there was only 1 patient in this group
2.Primary Outcome
Title Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)
Hide Description Due to insufficient sampling, AUCinf was not estimated.
Time Frame Up to 24 hours
Outcome Measure Data Not Reported
3.Primary Outcome
Title Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Up to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric
Arm/Group Title 6 to < 12 Years (10 mg ORF) 6 to < 12 Years (15 mg ORF) 6 to < 12 Years (20 mg ORF) ≥ 12 to ≤ 16 Years (10 mg ORF) ≥ 12 to ≤ 16 Years (15 mg ORF) ≥ 12 to ≤ 16 Years (20 mg ORF)
Hide Arm/Group Description:
Children from 6 to < 12 years received a single dose of 10 mg ORF
Children from 6 to < 12 years received a single dose of 15 mg ORF
Children from 6 to < 12 years received a single dose of 20 mg ORF
Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
Overall Number of Participants Analyzed 1 1 1 2 5 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
12.3 [1]   (NA) 16.6 [1]   (NA) 21.9 [1]   (NA) 8.3  (1.9) 26.6  (16.0) 26.2  (7.9)
[1]
Standard deviation not calculable since there was only 1 patient in this group
4.Primary Outcome
Title Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Up to 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric
Arm/Group Title 6 to < 12 Years (10 mg ORF) 6 to < 12 Years (15 mg ORF) 6 to < 12 Years (20 mg ORF) ≥ 12 to ≤ 16 Years (10 mg ORF) ≥ 12 to ≤ 16 Years (15 mg ORF) ≥ 12 to ≤ 16 Years (20 mg ORF)
Hide Arm/Group Description:
Children from 6 to < 12 years received a single dose of 10 mg ORF
Children from 6 to < 12 years received a single dose of 15 mg ORF
Children from 6 to < 12 years received a single dose of 20 mg ORF
Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
Overall Number of Participants Analyzed 1 1 1 2 5 8
Median (Full Range)
Unit of Measure: hour (h)
6
(6 to 6)
3
(3 to 3)
12
(12 to 12)
5.3
(4.6 to 6)
3
(1.5 to 4.5)
6
(4.4 to 24.1)
5.Primary Outcome
Title Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z)
Hide Description Due to insufficient sampling, Lamda z was not estimated.
Time Frame Up to 24 hours
Outcome Measure Data Not Reported
6.Primary Outcome
Title Single-dose PK Metric: Apparent Plasma Terminal Phase Half/Life (t1/2z)
Hide Description Due to insufficient sampling, t1/2z was not estimated.
Time Frame Up to 24 hours
Outcome Measure Data Not Reported
7.Primary Outcome
Title Single-dose PK Metric: Lag Time Was Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value (Tlag)
Hide Description Due to insufficient sampling, tlag was not estimated.
Time Frame Up to 24 hours
Outcome Measure Data Not Reported
8.Primary Outcome
Title Single- and Multiple-dose PK Metric: Mean Area Under the Plasma Concentration During Each Dosing Interval-time Curve From Hour 0 to 12 Hours of the First Dose of ORF (AUC 0-12)
Hide Description [Not Specified]
Time Frame Up to 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric
Arm/Group Title 6 to < 12 Years (10 mg ORF) 6 to < 12 Years (15 mg ORF) 6 to < 12 Years (20 mg ORF) ≥ 12 to ≤ 16 Years (10 mg ORF) ≥ 12 to ≤ 16 Years (15 mg ORF) ≥ 12 to ≤ 16 Years (20 mg ORF)
Hide Arm/Group Description:
Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
Overall Number of Participants Analyzed 2 2 1 4 8 9
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
67.5  (29.1) 114.5  (9.4) 112.8 [1]   (NA) 82.5  (13.4) 139.0  (105.2) 174.2  (112.7)
[1]
Standard deviation not calculable since there was only 1 patient in this group
9.Primary Outcome
Title Single- and Multiple-dose PK Metric: Maximum Observed Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Cmax 0-12)
Hide Description [Not Specified]
Time Frame Up to 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric
Arm/Group Title 6 to < 12 Years (10 mg ORF) 6 to < 12 Years (15 mg ORF) 6 to < 12 Years (20 mg ORF) ≥ 12 to ≤ 16 Years (10 mg ORF) ≥ 12 to ≤ 16 Years (15 mg ORF) ≥ 12 to ≤ 16 Years (20 mg ORF)
Hide Arm/Group Description:
Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
Overall Number of Participants Analyzed 2 2 1 5 9 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
9.4  (4.2) 23.5  (9.8) 21.9 [1]   (NA) 10.0  (2.3) 21.8  (14.2) 25.1  (14.2)
[1]
Standard deviation not calculable since there was only 1 patient in this group
10.Primary Outcome
Title Single- and Multiple-dose PK Metric: Time to Maximum Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Tmax 0-12)
Hide Description [Not Specified]
Time Frame Up to 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric
Arm/Group Title 6 to < 12 Years (10 mg ORF) 6 to < 12 Years (15 mg ORF) 6 to < 12 Years (20 mg ORF) ≥ 12 to ≤ 16 Years (10 mg ORF) ≥ 12 to ≤ 16 Years (15 mg ORF) ≥ 12 to ≤ 16 Years (20 mg ORF)
Hide Arm/Group Description:
Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
Overall Number of Participants Analyzed 2 2 1 5 9 11
Median (Full Range)
Unit of Measure: h
9
(6 to 12)
7.3
(3 to 11.7)
12
(12 to 12)
4.6
(2.8 to 12)
4.5
(1.5 to 12)
6
(3.3 to 11.9)
11.Primary Outcome
Title Single- and Multiple-dose PK Metric: Lag Time Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value From Hour 0 to 12 Hours of the First Dose of ORF (Tlag 0-12)
Hide Description Due to insufficient sampling, tlag 0-12 was not estimated.
Time Frame Up to 12 hours
Outcome Measure Data Not Reported
12.Primary Outcome
Title The Number of Patients With Adverse Events as a Measure of Safety
Hide Description [Not Specified]
Time Frame Adverse events (AEs) & serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion (AEs) & through 30 days following last study drug dose, or until last study visit, whichever was later (SAEs).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population (N = 30) was defined as the group of patients who received study drug
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description:
Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
Overall Number of Participants Analyzed 5 25
Measure Type: Number
Unit of Measure: participants
Death 0 0
Serious Adverse Event (SAE) 0 1
Any TEAE reported in ≥ 5% of participants 5 16
13.Secondary Outcome
Title Multiple-dose PK Metric: Minimum Observed Plasma Concentration Just Prior to the Next Dose (Cmin)
Hide Description [Not Specified]
Time Frame Up to 72 hours if all 5 doses were administered
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric
Arm/Group Title 6 to < 12 Years (10 mg ORF) 6 to < 12 Years (15 mg ORF) 6 to < 12 Years (20 mg ORF) ≥ 12 to ≤ 16 Years (10 mg ORF) ≥ 12 to ≤ 16 Years (15 mg ORF) ≥ 12 to ≤ 16 Years (20 mg ORF)
Hide Arm/Group Description:
Children from 6 to < 12 years who received multiple doses of 10 mg ORF
Children from 6 to < 12 years who received multiple doses of 15 mg ORF
Children from 6 to < 12 years who received multiple doses of 20 mg ORF
Children from ≥ 12 to ≤ 16 years who received multiple doses of 10 mg ORF
Children from ≥ 12 to ≤ 16 years who received multiple doses of 15 mg ORF
Children from ≥ 12 to ≤ 16 years who received multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
Overall Number of Participants Analyzed 1 1 0 3 4 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
15.5 [1]   (NA) 17.3 [1]   (NA) 4.8  (1.9) 11.9  (6.9) 19.1  (2.7)
[1]
Standard deviation not calculable since there was only 1 patient in this group
Time Frame Adverse events (AEs) & serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion (AEs) & through 30 days following last study drug dose, or until last study visit, whichever was later (SAEs).
Adverse Event Reporting Description AEs were learned of through spontaneous reports or patient interview.
 
Arm/Group Title 6 to < 12 Years ≥ 12 to ≤ 16 Years
Hide Arm/Group Description Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses). Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
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 (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      1/25 (4.00%)    
General disorders     
Medical device complication  1  0/5 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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 (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      16/25 (64.00%)    
Blood and lymphatic system disorders     
Anaemia  1  1/5 (20.00%)  1/25 (4.00%) 
Gastrointestinal disorders     
Constipation * 1  1/5 (20.00%)  6/25 (24.00%) 
Nausea * 1  1/5 (20.00%)  3/25 (12.00%) 
Vomiting * 1  2/5 (40.00%)  5/25 (20.00%) 
General disorders     
Pyrexia  1  0/5 (0.00%)  3/25 (12.00%) 
Injury, poisoning and procedural complications     
Scratch * 1  1/5 (20.00%)  0/25 (0.00%) 
Seroma * 1  1/5 (20.00%)  0/25 (0.00%) 
Investigations     
Oxygen saturation decreased  1  0/5 (0.00%)  2/25 (8.00%) 
Respiratory rate decreased  1  1/5 (20.00%)  4/25 (16.00%) 
Nervous system disorders     
Dizziness * 1  2/5 (40.00%)  1/25 (4.00%) 
Headache * 1  1/5 (20.00%)  1/25 (4.00%) 
Sedation * 1  1/5 (20.00%)  0/25 (0.00%) 
Renal and urinary disorders     
Urinary retention * 1  1/5 (20.00%)  1/25 (4.00%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  1/5 (20.00%)  0/25 (0.00%) 
Pruritus * 1  1/5 (20.00%)  2/25 (8.00%) 
Rash * 1  0/5 (0.00%)  2/25 (8.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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
Name/Title: Medical Services
Organization: Purdue Pharma L.P.
Phone: 888-726-7535, option 1
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01160614     History of Changes
Other Study ID Numbers: OTR1020
2010-020510-29 ( EudraCT Number )
First Submitted: July 8, 2010
First Posted: July 12, 2010
Results First Submitted: July 17, 2012
Results First Posted: August 21, 2012
Last Update Posted: October 15, 2012