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

July 8, 2010
October 11, 2012
July 2010
August 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    Due to insufficient sampling, AUCinf was not estimated.
  • Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
  • Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
  • Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    Due to insufficient sampling, Lamda z was not estimated.
  • Single-dose PK Metric: Apparent Plasma Terminal Phase Half/Life (t1/2z) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    Due to insufficient sampling, t1/2z was not estimated.
  • 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 ] [ Designated as safety issue: No ]
    Due to insufficient sampling, tlag was not estimated.
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Due to insufficient sampling, tlag 0-12 was not estimated.
  • 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). ] [ Designated as safety issue: Yes ]
To characterize the pharmacokinetics (PK) and safety of single-dose ORF tablets [ Time Frame: The primary outcome will be measured in 24 hours ] [ Designated as safety issue: Yes ]
The primary objective is to characterize the pharmacokinetics (PK) and safety of single-dose ORF tablets in pediatric patients aged 6 to16 years, inclusive.
Complete list of historical versions of study NCT01160614 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
To examine ORF multiple-dose PK [ Time Frame: 72 hours if all 5 doses are administered ] [ Designated as safety issue: Yes ]
The secondary objective is to examine ORF multiple- dose PK in pediatric patients aged 6 to16 years, inclusive.
Not Provided
Not Provided
 
Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients
An Open-label Study to Characterize the Pharmacokinetics and Safety of Oxycodone Hydrochloride q12h Controlled-Release (ORF) Tablets in Pediatric Patients Aged 6 to 16 Years Inclusive, Who Require Opioid Analgesia

The purpose of this study is to characterize the pharmacokinetics (PK) of single-dose ORF tablets in pediatric patients aged 6 to 16 years, inclusive.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Opioid Analgesia
Drug: Oxycodone hydrochloride controlled-release (ORF) tablets
Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours
Experimental: ORF Tablets
ORF Tablets
Intervention: Drug: Oxycodone hydrochloride controlled-release (ORF) tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent provided by the parent or legal guardian and patient assent, when appropriate.
  • Children of either gender, aged 6 to 16 years, inclusive.
  • Have or are expected to have moderate to severe pain for an extended period of time requiring inpatient opioid analgesic treatment for at least 12 hours as this is the minimum duration of study period treatment.
  • In order to receive the first oral dose, patients must have respiratory stability, including a sustained SpO2 of at least 92% with or without supplemental oxygen during the 15 minute period just prior to dosing.
  • Must be inpatient for the treatment period of the study.
  • The patient's anticipated opioid analgesic requirement over the first 12 hours that will follow administration of ORF must be equivalent to at least 10 mg of intravenous (IV) morphine.
  • Have adequate pain control during the 6 hours prior to study drug administration, based on appropriate clinical assessment.
  • Must be sufficiently alert to communicate and complete the faces pain scales-revised (FPS-R) or 100-mm visual analogue scale (VAS).
  • Females who are of child bearing potential must be using an adequate and reliable method of contraception (e.g., barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception) or be abstinent.
  • If female, must have a negative pregnancy test and be non-lactating.
  • Must be able to swallow tablets whole.
  • Must have stable vital signs.
  • Must have vascular access to facilitate blood draws.
  • Must be willing and able to participate in all aspects of this study involving use of oral medications, patient evaluation, and phlebotomy, as evidenced by written informed consent from the parent or legal guardian and written patient assent when required by the local IRB/EC.
  • Must be willing to have up to 10 milliliters (mL) of blood collected for blood analysis (7 mL for primary PK and 3 mL for secondary PK analysis); and up to 10 mL of blood for pre-specified safety laboratory tests, without safety concerns.
  • Must be treated with an opioid for a minimum of 96 hours prior to first dose of ORF.

Exclusion Criteria:

  • Any history of hypersensitivity or medical contraindication for the use of oxycodone (this does not exclude patients with a history of expected opioid-related adverse events (AEs), such as light-headedness, dizziness, sedation, nausea, or vomiting).
  • Any current history of medical or surgical conditions that might significantly interfere with the gastrointestinal absorption, distribution, metabolism, or excretion of oxycodone (this includes any history of serious disease+ of the gastrointestinal tract, liver, kidneys, and/or blood-forming organs).
  • Received oxycodone in the 24 hours prior to study drug administration. .
  • Received epidural (or regional) anesthesia < 12 hours prior to the first oral dose of ORF.
  • A current history of malabsorption syndrome.
  • A current diagnosis of sleep apnea within the last year.
  • Reduced renal function (serum creatinine > 1.8 X the upper limit of normal for age).
  • Hepatic impairment as evidenced by serum alanine amino transferase (ALT) or serum aspartate amino transferase (AST) > 5 times the upper limit of normal (ULN) for age.
  • Currently taking any medications which are CYP3A4 inhibitors.
  • Impaired respiratory reserve including severe acute or chronic lung disease, or patients receiving mechanical respiratory support, including mechanical ventilation, BIPAP, or CPAP 6 hours prior to the first oral dose and during the entire oral treatment period.
  • Impaired cardiovascular stability (e.g., the day of surgery for cardiac surgery patients).
  • Participated in a clinical drug study within 30 days preceding the initial dose in this study.
  • Patients who have had surgery within 96 hours prior to the day of the first dose of study drug.
  • Deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Finland,   Australia,   New Zealand
 
NCT01160614
OTR1020, 2010-020510-29
No
Purdue Pharma LP
Purdue Pharma LP
Not Provided
Not Provided
Purdue Pharma LP
October 2012

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