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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01192295




Registration number
NCT01192295
Ethics application status
Date submitted
30/08/2010
Date registered
1/09/2010
Date last updated
23/03/2020

Titles & IDs
Public title
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Scientific title
An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children From Ages 6 to 16 Years Old, Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics
Secondary ID [1] 0 0
2010-020471-23
Secondary ID [2] 0 0
OTR3001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Oxycodone HCl controlled-release - Oxycodone hydrochloride (HCl) controlled-release (CR)


Treatment: Drugs: Oxycodone HCl controlled-release tablets
Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number of Participants With Adverse Events as a Measure of Safety.
Timepoint [1] 0 0
Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
Secondary outcome [1] 0 0
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Timepoint [1] 0 0
Baseline to week 4
Secondary outcome [2] 0 0
Pain Right Now Assessment by Patients Aged = 12 to = 16 Years
Timepoint [2] 0 0
Baseline to week 4
Secondary outcome [3] 0 0
Use of Supplemental Pain Medication
Timepoint [3] 0 0
Baseline to week 4
Secondary outcome [4] 0 0
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
Timepoint [4] 0 0
Baseline to week 4 or early discontinuation
Secondary outcome [5] 0 0
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years
Timepoint [5] 0 0
Baseline to week 4
Secondary outcome [6] 0 0
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged = 12 to = 16 Years
Timepoint [6] 0 0
Baseline to week 4
Secondary outcome [7] 0 0
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Timepoint [7] 0 0
Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]
Secondary outcome [8] 0 0
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss
Timepoint [8] 0 0
Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]
Secondary outcome [9] 0 0
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax)
Timepoint [9] 0 0
Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]
Secondary outcome [10] 0 0
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio
Timepoint [10] 0 0
Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]

Eligibility
Key inclusion criteria
Inclusion Criteria include:

* Male and female patients aged 6 to 16 years, inclusive, who are expected to require ongoing around-the-clock opioid treatment equivalent to at least 20-mg daily dose of oxycodone for at least 2 weeks for management of moderate to severe (based on the investigator's judgment) malignant or nonmalignant pain.
* Patients must be opioid tolerant, ie, have been treated with opioids for at least the 5 consecutive days prior to dosing and with at least 20 mg daily of oxycodone or the equivalent during at least the last 48 hours prior to the start of study drug dosing and have tolerated the therapy, as demonstrated at the start of study drug dosing.
* Patients who are currently using transdermal fentanyl should have been on the patch for at least 3 days before removing the patch and oxycodone hydrochloride (HCl) controlled-release (CR) treatment can only be initiated at least 18 hours following the removal of the transdermal fentanyl patch.
* Patients must not require more than a 240-mg total daily dose of oxycodone HCl CR tablets.
* Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.
* Patients must not be currently on an investigational medication/therapy at the start of screening or during the study.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria include:

* Female patients who are pregnant or lactating.
* Patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation]).
* Patients who have received epidural opioids < 2 hours prior to the first dose of study drug or who have received epidural morphine < 12 hours prior to the first dose of study drug.
* Patients who are contraindicated for the use of opioids.
* Patients who are contraindicated for blood sampling.
* Patients who are currently being maintained on methadone for pain.
* Patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices.
* Patients who have had surgery within 5 days prior to Day 1 (day of first dose of study drug).
* Patients who, in the investigator's opinion, have an underlying gastrointestinal condition or other disorder that may predispose them to obstruction.

Other protocol-specific inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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 3
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
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Alabama
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California
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Connecticut
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Delaware
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Florida
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Illinois
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Kentucky
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Michigan
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Missouri
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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Greece
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Athens
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Hungary
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Budapest
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Israel
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Beersheba
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Peta? Tiqwa
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Israel
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Ramat Gan
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New Zealand
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Auckland
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Romania
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Targu Mures
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Spain
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Barcelona
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United Kingdom
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Sheffield

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 safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
Trial website
https://clinicaltrials.gov/study/NCT01192295
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01192295