PainPhase 3NCT01369615

Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001

A Phase 3 study of Pain, run by Purdue Pharma LP at 14 sites in 2 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 long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week… Read more about this study

Who is it for?: Ages 6 to 17 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: 23 participants
Where: 14 sitesin 2 countries
Study dates: Oct 2011to May 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 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female patients aged 6 to 17 years, inclusive, who completed the 4-week study drug treatment in study OTR3001 and who, based on the investigator's judgment, will benefit from continuing treatment with oxycodone HCl CR 20 to 240 mg/day for the management of moderate to severe malignant or nonmalignant pain;
Patients must have tolerated the oxycodone HCl CR therapy in OTR3001 as demonstrated at the start of the study;
Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.

Who cannot join

Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion, disqualify them from participation in the study;
Female patients who are pregnant or lactating;
Patients requiring opioid at doses equivalent to < 20 mg/day or > 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain;
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 are contraindicated for the use of opioids;
Patients who are currently being maintained on methadone for pain;

Show all 10Show fewer

Patients who have an abnormality on vital signs, physical examination, or laboratory testing significant enough that the investigator deems the patient is not appropriate for the study;
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 currently taking an investigational medication/therapy other than the study drug (oxycodone HCl CR) at the start of screening or during the study.
Other protocol specific inclusion/exclusion criteria may apply.

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States13 sites

Akron Children's Hospital
Akron, Ohio, 44308
Children's Hospital Colorado
Aurora, Colorado, 80045
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Presbyterian Blume Pediatric Hematology & Oncology Clinic
Charlotte, North Carolina, 28204
Children's Medical Center of Dallas
Dallas, Texas, 75235
University of Kentucky
Lexington, Kentucky, 40536
Jackson Memorial Hospital
Miami, Florida, 33136
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
New York University Langone Medical Center
New York, New York, 10016
The Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Bayview Research Group, LLC
Paramount, California, 90723
Mercy Clinic Children's Cancer and Hematology Center
St Louis, Missouri, 63141
Stony Brook University Hospital
Stony Brook, New York, 11794

Other trials in United States

Israel1 site

Schneider Children Medical Center of Israel
Petah Tikva, 49202

Other trials in Israel

About this study

Official title: An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study

Conditions: Pain
Being tested: Oxycodone hydrochloride controlled-release tablets
Keywords: Malignant pain, Nonmalignant pain, Pain, Pediatric, Opioid, Moderate to severe
Medical subject headings: Pain

What participants receive

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

Oxycodone hydrochloride controlled-release tabletsDrug
Also called OxyContin
Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.

Study groups in NCT01369615
Study group	Role	What they receive
Oxycodone HCl controlled-release	Experimental	Oxycodone hydrochloride controlled-release tablets Receives: Drug: Oxycodone hydrochloride 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 included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population.
Measured: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).

Timeline

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

Oct 2011May 2014

First posted9 Jun 2011 (estimated)
Study startOct 2011
Primary completionDec 2013
Study completionMay 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: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01369615
Sponsor's protocol ID: OTR3002
Other IDs: 2011-002235-26
Status last verified: Aug 2015
First submitted: 7 Jun 2011
Last updated: 9 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study
ClinicalTrials.gov ID: NCT01369615
Acronym / sponsor ID: OTR3002
Conditions: Pain
Keywords: Malignant pain, Nonmalignant pain, Pain, Pediatric, Opioid, Moderate to severe
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Dec 2013 (actual)
Study completion: May 2014 (actual)
First posted: 9 Jun 2011 (estimated)
Results: Posted 15 Jan 2015

Clinical summary

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

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 hydrochloride controlled-release tabletsOxycodone hydrochloride controlled-release tablets

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male and female patients aged 6 to 17 years, inclusive, who completed the 4-week study drug treatment in study OTR3001 and who, based on the investigator's judgment, will benefit from continuing treatment with oxycodone HCl CR 20 to 240 mg/day for the management of moderate to severe malignant or nonmalignant pain;
Patients must have tolerated the oxycodone HCl CR therapy in OTR3001 as demonstrated at the start of the study;
Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.

Key exclusion criteria (10 listed)

Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion, disqualify them from participation in the study;
Female patients who are pregnant or lactating;
Patients requiring opioid at doses equivalent to < 20 mg/day or > 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain;
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 are contraindicated for the use of opioids;

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 tabletsAlso: OxyContinOxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 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 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).
Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population.

Results and safety

Results posted to the registry on 15 Jan 2015, 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	9	9
≥ 12 to ≤ 16 Years	14	12

Primary outcome: The Number of Participants With Adverse Events as a Measure of Safety.

Time frame: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).. Number. Unit: participants

Measure	6 to < 12 Years n = 9	≥ 12 to ≤ 16 Years n = 14
Serious adverse events	3	2
All other adverse events in ≥ 5% of patients	8	8

Population analysed: The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.

Adverse events

Time frame: Adverse events (AEs) were reported from start of study participation through the period beyond study completion.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
6 to < 12 Years	3 of 9 (33.3%)	8 of 9 (88.9%)	Not reported
≥ 12 to ≤ 16 Years	2 of 14 (14.3%)	8 of 14 (57.1%)	Not reported

Limitations and caveats (from the sponsor): Enrollment for study OTR3002 was closed by Purdue Pharma L.P. on 01-January-2014 due to administrative reasons not related to safety. Interpretation is limited by the small number of patients in each age group in this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Product InformationLink provided by the sponsor.

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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.

14 sites in 2 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 14 sites in 2 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 3 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 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Israel. 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 15 Jan 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 6 months (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?

On the ClinicalTrials.gov record for NCT01369615.

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 9 Sep 2015.