Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01160614
First received: July 8, 2010
Last updated: October 11, 2012
Last verified: October 2012
Results First Received: July 17, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Opioid Analgesia
Intervention: Drug: Oxycodone hydrochloride controlled-release (ORF) tablets

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Pediatric patients who were anticipated to have pain requiring opioid analgesia.

Reporting Groups
  Description
6 to < 12 Years 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).
≥ 12 to ≤ 16 Years 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).

Participant Flow:   Overall Study
    6 to < 12 Years     ≥ 12 to ≤ 16 Years  
STARTED     5     25  
COMPLETED     5     23  
NOT COMPLETED     0     2  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
6 to < 12 Years 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).
≥ 12 to ≤ 16 Years 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 Total of all reporting groups

Baseline Measures
    6 to < 12 Years     ≥ 12 to ≤ 16 Years     Total  
Number of Participants  
[units: participants]
  5     25     30  
Age  
[units: Years]
Mean ± Standard Deviation
  10.6  ± 0.9     14.1  ± 1.6     13.5  ± 2.0  
Gender  
[units: participants]
     
Female     3     14     17  
Male     2     11     13  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     3     4  
White     4     21     25  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]   [ Time Frame: Up to 24 hours ]

2.  Primary:   Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Up to 24 hours ]

3.  Primary:   Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)   [ Time Frame: Up to 24 hours ]

4.  Primary:   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)   [ Time Frame: Up to 12 hours ]

5.  Primary:   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)   [ Time Frame: Up to 12 hours ]

6.  Primary:   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)   [ Time Frame: Up to 12 hours ]

7.  Primary:   The Number of Patients With Adverse Events as a Measure of Safety   [ 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). ]

8.  Secondary:   Multiple-dose PK Metric: Minimum Observed Plasma Concentration Just Prior to the Next Dose (Cmin)   [ Time Frame: Up to 72 hours if all 5 doses were administered ]

9.  Primary:   Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)   [ Time Frame: Up to 24 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Primary:   Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z)   [ Time Frame: Up to 24 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Primary:   Single-dose PK Metric: Apparent Plasma Terminal Phase Half/Life (t1/2z)   [ Time Frame: Up to 24 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Primary:   Single-dose PK Metric: Lag Time Was Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value (Tlag)   [ Time Frame: Up to 24 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Primary:   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)   [ Time Frame: Up to 12 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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


No publications provided


Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01160614     History of Changes
Other Study ID Numbers: OTR1020, 2010-020510-29
Study First Received: July 8, 2010
Results First Received: July 17, 2012
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
New Zealand: Medsafe
Australia: Department of Health and Ageing Therapeutic Goods Administration