PainPhase 3NCT01192295
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
A Phase 3 study of Pain, run by Purdue Pharma LP at 47 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Pain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 47 sitesin 8 countries
- Study dates
- Nov 2010to Jul 2014
- Phase
- Phase 3
- 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
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
47 sites in 8 countries.
47 sites in 8 countries
United States35 sites
Akron Children's Hospital
Akron, Ohio, 44308
The Children's Hospital
Aurora, Colorado, 80045
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Presbyterian Blume Pediatric Hematology and Oncology Clinic
Charlotte, North Carolina, 28204
Children's Memorial Hospital
Chicago, Illinois, 60614
Children's Medical Ctr of Dallas
Dallas, Texas, 75235
Duke University Medical Center
Durham, North Carolina, 22710
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Memorial Regional Hospital
Hollywood, Florida, 33021
University of Kentucky
Lexington, Kentucky, 40536
Loma Linda University Medical Center
Loma Linda, California, 92354
Children's Hospital Los Angeles
Los Angeles, California, 90027
Jackson Memorial Hospital/University of Miami
Miami, Florida, 33136
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
University of South Alabama, Children's and Women's Hospital
Mobile, Alabama, 36604
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
New York University Langone Medical Center
New York, New York, 10016
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
Department of Pediatrics, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
The Children's Hospital at OUMC
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868
LS Packard Children's Hospital
Palo Alto, California, 94304
Bayview Research Group, LLC
Paramount, California, 90723
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Pediatric Hematology and Oncology, Virginia Commonwealth University Health System
Richmond, Virginia, 23298
Shriners Hospitals for Children Northern California
Sacramento, California, 95817
Primary Children's Medical Center
Salt Lake City, Utah, 84113
St. John's Mercy Medical Center
St Louis, Missouri, 63141
Stony Brook University Hospital
Stony Brook, New York, 11794
Tampa General Hospital
Tampa, Florida, 33606
Research Facility
The Woodlands, Texas, 77381
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Israel5 sites
Soroka University Medical Center
Beersheba, 84101
Mayer Children Hospital, Rambam Medical Center
Haifa, 31096
Hadassah Medical Organization, Ein Kerem
Jerusalem, 91120
Schneider Children Medical Center of Israel
Petah Tikva, 49202
Sheba Medical Center
Ramat Gan, 52621
Greece2 sites
Agia Sophia Children's Hospital
Athens, 115 27
Aglaia Kyriakou - Elpida Children's Oncology Unit
Athens, 115 27
Hungary1 site
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
Budapest, H-1094
Romania1 site
Spitalul Clinic Judetean de Urgenta Targu Mures, Clinica pediatrie I
Târgu Mureş, 540136
About this study
Official 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
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.
- Conditions
- Pain
- Being tested
- Oxycodone HCl controlled-release tablets
- Keywords
- Malignant pain, Nonmalignant pain, Pediatric, Opioid, Moderate to severe malignant or nonmalignant pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone HCl controlled-release tabletsDrug
Also called OxyContin
Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone HCl controlled-release | Experimental | Oxycodone hydrochloride (HCl) controlled-release (CR) Receives: Drug: Oxycodone HCl controlled-release tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Adverse Events as a Measure of Safety.
Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.
Measured: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
Secondary outcomes (10)
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with "no hurt" at the far left and "hurts worst" at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.
Measured: Baseline to week 4
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked "no pain" and the opposite end marked as "pain as bad as it could be." The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the "no pain" end to the patient's mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.
Measured: Baseline to week 4
Use of Supplemental Pain Medication
Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight.
Measured: Baseline to week 4
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group.
Measured: Baseline to week 4 or early discontinuation
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years
The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.
Measured: Baseline to week 4
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years
The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.
Measured: Baseline to week 4
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. Cmax was taken as the maximum simulated oxycodone concentration over the dosing interval and Cmin was the simulated oxycodone concentration when time was equal to 12 hours. Steady-state Cmin and Cmax were derived from the accumulation ratio.
The following PK parameters are presented: Cmin / Cmax (minimum / maximum concentration); Cmin,ss / Cmax,ss (Cmin / Cmax at steady state); CAVGss (average concentration at steady state).
Measured: 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]
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss
A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. First-dose area under the concentration-time curve (AUC) was derived from the accumulation ratio. For all calculations, the dosing interval was assumed to be 12 hours.
The following PK parameters are presented: AUCtau (area under the concentration-time curve from time zero to time equal to dosing interval); AUCss (AUC at steady state).
Measured: 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]
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax)
A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose.
Measured: 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]
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio
A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. The accumulation ratio is used to derive steady-state Cmin and Cmax and first-dose area under the concentration-time curve (AUCtau).
Measured: 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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2014
- Study completionJul 2014
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 PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192295
- Sponsor's protocol ID
- OTR3001
- Other IDs
- 2010-020471-23
- Status last verified
- Mar 2020
- First submitted
- 30 Aug 2010
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01192295
- Acronym / sponsor ID
- OTR3001
- Conditions
- Pain
- Keywords
- Malignant pain, Nonmalignant pain, Pediatric, Opioid, Moderate to severe malignant or nonmalignant pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Posted 6 Feb 2015
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxycodone HCl controlled-release | Experimental | Drug: Oxycodone HCl controlled-release tabletsOxycodone hydrochloride (HCl) controlled-release (CR) |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 HCl controlled-release tabletsAlso: OxyContinOxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours. | Drug | Oxycodone HCl controlled-release |
Primary outcome
The Number of Participants With Adverse Events as a Measure of Safety.
Time frame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.
10 secondary outcomes
Pain Right Now Assessment by Patients Aged 6 to < 12 Years
Time frame: Baseline to week 4
Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
Time frame: Baseline to week 4
Use of Supplemental Pain Medication
Time frame: Baseline to week 4
Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
Time frame: Baseline to week 4 or early discontinuation
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years
Time frame: Baseline to week 4
Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years
Time frame: Baseline to week 4
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
Time frame: 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]
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss
Time frame: 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]
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax)
Time frame: 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]
Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio
Time frame: 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]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
47 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Pain, run by Purdue Pharma LP at 47 sites in 8 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 6 inclusion and 10 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 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Israel, Greece, Hungary, New Zealand and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Feb 2015). 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?
The Number of Participants With Adverse Events as a Measure of Safety. (time frame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2020.