Opioid AnalgesiaPhase 1NCT01160614

Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients

A Phase 1 study of Opioid Analgesia, run by Purdue Pharma LP at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 6 to 16 years
Conditions the study is for: Opioid Analgesia
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 17 sitesin 4 countries
Study dates: Jul 2010to Aug 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

17 sites in 4 countries.

Country

City, postcode or hospital

17 sites in 4 countries

United States13 sites

Akron Children's Hospital
Akron, Ohio, 44308
F3900 C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
The Children's Hospital Association
Aurora, Colorado, 80045
Children's Med Center of Dallas
Dallas, Texas, 75235
Arkansas Childrens Hospital
Little Rock, Arkansas, 72202-3591
Research Facility
Miami, Florida, 33136
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
The Children's Hospital at OUMC
Oklahoma City, Oklahoma, 73104-5070
LS Packard Children's Hospital
Palo Alto, California, 94304
Maricopa Medical Center
Phoenix, Arizona, 85008
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
University of Washington School of Medicine - Harborview Medical Center
Seattle, Washington, 98104-2420
Scott & White Memorial Hospital & Clinic
Temple, Texas, 76508

Other trials in United States

Finland2 sites

Helsinki University Central Hospital/Children and Adolescent Hospital
Helsinki, 00290
Kuopio University Hospital/Operative Services and Intensive Care
Kuopio, 70211

Other trials in Finland

Australia1 site

The Royal Children's Hospital
Parkville, 3052

Other trials in Australia

New Zealand1 site

Waikato Clinical Research (2008) Ltd
Hamilton, 3214

Other trials in New Zealand

About this study

Official 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

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.

Conditions: Opioid Analgesia
Being tested: Oxycodone hydrochloride controlled-release (ORF) tablets
Keywords: Pediatric, Post-operative, Nonsurgical, patients, Opioid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxycodone hydrochloride controlled-release (ORF) tabletsDrug
Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours

Study groups in NCT01160614
Study group	Role	What they receive
ORF Tablets	Experimental	ORF Tablets Receives: Drug: Oxycodone hydrochloride controlled-release (ORF) tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]
Measured: Up to 24 hours
Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)
Due to insufficient sampling, AUCinf was not estimated.
Measured: Up to 24 hours
Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)
Measured: Up to 24 hours
Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)
Measured: Up to 24 hours
Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z)
Due to insufficient sampling, Lamda z was not estimated.
Measured: Up to 24 hours
Single-dose PK Metric: Apparent Plasma Terminal Phase Half/Life (t1/2z)
Due to insufficient sampling, t1/2z was not estimated.
Measured: Up to 24 hours
Single-dose PK Metric: Lag Time Was Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value (Tlag)
Due to insufficient sampling, tlag was not estimated.
Measured: Up to 24 hours
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)
Measured: Up to 12 hours
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)
Measured: Up to 12 hours
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)
Measured: Up to 12 hours
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)
Due to insufficient sampling, tlag 0-12 was not estimated.
Measured: Up to 12 hours
The Number of Patients With Adverse Events as a Measure of Safety
Measured: 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 outcomes (1)

Multiple-dose PK Metric: Minimum Observed Plasma Concentration Just Prior to the Next Dose (Cmin)
Measured: Up to 72 hours if all 5 doses were administered

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Aug 2011

First posted12 Jul 2010 (estimated)
Study startJul 2010
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid AnalgesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01160614
Sponsor's protocol ID: OTR1020
Other IDs: 2010-020510-29
Status last verified: Oct 2012
First submitted: 8 Jul 2010
Last updated: 15 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01160614
Acronym / sponsor ID: OTR1020
Conditions: Opioid Analgesia
Keywords: Pediatric, Post-operative, Nonsurgical, patients, Opioid
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 12 Jul 2010 (estimated)
Results: Posted 21 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ORF Tablets	Experimental	Drug: Oxycodone hydrochloride controlled-release (ORF) tabletsORF Tablets

Who may qualify

Ages: 6 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (16 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxycodone hydrochloride controlled-release (ORF) tabletsOxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours	Drug	ORF Tablets

Primary outcome

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
Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)
Time frame: Up to 24 hours
Due to insufficient sampling, AUCinf was not estimated.
Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 24 hours
Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)
Time frame: Up to 24 hours
Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z)
Time frame: Up to 24 hours
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
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
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
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
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
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
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).

1 secondary outcome

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

Results and safety

Results posted to the registry on 21 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
6 to < 12 Years	5	5
≥ 12 to ≤ 16 Years	25	23

Primary outcome: 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. Mean (Standard Deviation). Unit: ng*h/mL

Measure	6 to < 12 Years (10 mg ORF) n = 1	6 to < 12 Years (15 mg ORF) n = 1	6 to < 12 Years (20 mg ORF) n = 1	≥ 12 to ≤ 16 Years (10 mg ORF) n = 2	≥ 12 to ≤ 16 Years (15 mg ORF) n = 5	≥ 12 to ≤ 16 Years (20 mg ORF) n = 8
Value	129.2 (NA)	121.1 (NA)	272.2 (NA)	85.5 (39.3)	193.0 (149.4)	264.4 (128.1)

Population analysed: 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

Primary outcome: Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)

Time frame: Up to 24 hours

The sponsor has not posted figures for this outcome.

Primary outcome: Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)

Time frame: Up to 24 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	6 to < 12 Years (10 mg ORF) n = 1	6 to < 12 Years (15 mg ORF) n = 1	6 to < 12 Years (20 mg ORF) n = 1	≥ 12 to ≤ 16 Years (10 mg ORF) n = 2	≥ 12 to ≤ 16 Years (15 mg ORF) n = 5	≥ 12 to ≤ 16 Years (20 mg ORF) n = 8
Value	12.3 (NA)	16.6 (NA)	21.9 (NA)	8.3 (1.9)	26.6 (16.0)	26.2 (7.9)

Population analysed: 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

Primary outcome: Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)

Time frame: Up to 24 hours. Median (Full Range). Unit: hour (h)

Measure	6 to < 12 Years (10 mg ORF) n = 1	6 to < 12 Years (15 mg ORF) n = 1	6 to < 12 Years (20 mg ORF) n = 1	≥ 12 to ≤ 16 Years (10 mg ORF) n = 2	≥ 12 to ≤ 16 Years (15 mg ORF) n = 5	≥ 12 to ≤ 16 Years (20 mg ORF) n = 8
Value	6 (6 to 6)	3 (NA)	12 (NA)	5.3 (1.011)	3 (1.26)	6 (6.663)

Population analysed: 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

1 secondary outcome is reported in the full results.

Adverse events

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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
6 to < 12 Years	0 of 5 (0%)	5 of 5 (100%)	Not reported
≥ 12 to ≤ 16 Years	1 of 25 (4%)	16 of 25 (64%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Opioid Analgesia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Opioid Analgesia, run by Purdue Pharma LP at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Finland, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01160614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.