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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01160614




Registration number
NCT01160614
Ethics application status
Date submitted
8/07/2010
Date registered
12/07/2010
Date last updated
15/10/2012

Titles & IDs
Public title
Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients
Scientific title
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
Secondary ID [1] 0 0
2010-020510-29
Secondary ID [2] 0 0
OTR1020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Analgesia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oxycodone hydrochloride controlled-release (ORF) tablets

Experimental: ORF Tablets - ORF Tablets


Treatment: Drugs: Oxycodone hydrochloride controlled-release (ORF) tablets
Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]
Timepoint [1] 0 0
Up to 24 hours
Primary outcome [2] 0 0
Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)
Timepoint [2] 0 0
Up to 24 hours
Primary outcome [3] 0 0
Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)
Timepoint [3] 0 0
Up to 24 hours
Primary outcome [4] 0 0
Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)
Timepoint [4] 0 0
Up to 24 hours
Primary outcome [5] 0 0
Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z)
Timepoint [5] 0 0
Up to 24 hours
Primary outcome [6] 0 0
Single-dose PK Metric: Apparent Plasma Terminal Phase Half/Life (t1/2z)
Timepoint [6] 0 0
Up to 24 hours
Primary outcome [7] 0 0
Single-dose PK Metric: Lag Time Was Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value (Tlag)
Timepoint [7] 0 0
Up to 24 hours
Primary outcome [8] 0 0
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)
Timepoint [8] 0 0
Up to 12 hours
Primary outcome [9] 0 0
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)
Timepoint [9] 0 0
Up to 12 hours
Primary outcome [10] 0 0
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)
Timepoint [10] 0 0
Up to 12 hours
Primary outcome [11] 0 0
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)
Timepoint [11] 0 0
Up to 12 hours
Primary outcome [12] 0 0
The Number of Patients With Adverse Events as a Measure of Safety
Timepoint [12] 0 0
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).
Secondary outcome [1] 0 0
Multiple-dose PK Metric: Minimum Observed Plasma Concentration Just Prior to the Next Dose (Cmin)
Timepoint [1] 0 0
Up to 72 hours if all 5 doses were administered

Eligibility
Key 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.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Finland
State/province [13] 0 0
Helsinki
Country [14] 0 0
Finland
State/province [14] 0 0
Kuopio
Country [15] 0 0
New Zealand
State/province [15] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Purdue Pharma LP
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01160614
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01160614