CompletedNCT01369615Updated Sep 9, 2015Results posted

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

A Phase 3 interventional study of Oxycodone hydrochloride controlled-release tablets in Pain, sponsored by Purdue Pharma LP. Completed at 14 sites in 2 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-09-09.

Sponsored by Purdue Pharma LP · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 23
Allocation: Not applicable
Ages: 6 Years to 17 Years
Sex: All

Study 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 treatment period in OTR3001.

Conditions studied

Pain

Keywords

Malignant pain
Nonmalignant pain
Pain
Pediatric
Opioid
Moderate to severe

In context

Lead sponsor

Purdue Pharma LP is the lead sponsor of 58 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria include:

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;
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 23 participants (actual)

Study arms

Experimental
Oxycodone HCl controlled-release
Oxycodone hydrochloride controlled-release tablets
Drug: Oxycodone hydrochloride controlled-release tablets

Interventions

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

What researchers measure

Primary outcomes

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

Results

Posted Jan 15, 2015

Limitations and caveats

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.

Participant flow

First Patient First Visit: 05-January-2012; Last Patient Last Visit: 09-December-2013. The study was conducted at 14 medical/research sites in the United States and Israel.

Participant flow — Overall Study
Milestone	6 to < 12 Years	≥ 12 to ≤ 16 Years
Started	9	14
Completed	9	12
Not completed	0	2
Withdrew: Withdrawal by subject	0	1
Withdrew: Lost to follow-up	0	1

Outcome measures

PrimaryThe 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.

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

The Number of Participants With Adverse Events as a Measure of Safety.
participants	6 to < 12 Years	≥ 12 to ≤ 16 Years
Serious adverse events	3	2
All other adverse events in ≥ 5% of patients	8	8

Adverse events

Collected over Adverse events (AEs) were reported from start of study participation through the period beyond study completion.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
6 to < 12 Years	—	3/9 (33.3%)	8/9 (88.9%)
≥ 12 to ≤ 16 Years	—	2/14 (14.3%)	8/14 (57.1%)

Most frequent serious events

Most frequent serious events
Event	6 to < 12 Years	≥ 12 to ≤ 16 Years
Sickle cell anaemia with crisisCongenital, familial and genetic disorders	1/9	1/14
ConstipationGastrointestinal disorders	1/9	0/14
PyrexiaGeneral disorders	1/9	0/14
VomitingGastrointestinal disorders	0/9	1/14
Back painMusculoskeletal and connective tissue disorders	0/9	1/14
HeadacheNervous system disorders	0/9	1/14

Most frequent other events

Showing 10 of 62

Most frequent other events
Event	6 to < 12 Years	≥ 12 to ≤ 16 Years
PyrexiaGeneral disorders	3/9	2/14
VomitingGastrointestinal disorders	2/9	2/14
EpistaxisRespiratory, thoracic and mediastinal disorders	2/9	0/14
AnaemiaBlood and lymphatic system disorders	1/9	0/14
LymphadenopathyBlood and lymphatic system disorders	1/9	0/14
External ear painEar and labyrinth disorders	1/9	0/14
ConjunctivitisEye disorders	1/9	0/14
Eye painEye disorders	1/9	0/14
MydriasisEye disorders	1/9	0/14
ConstipationGastrointestinal disorders	1/9	1/14

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)	6 to < 12 Years	≥ 12 to ≤ 16 Years	Total
Mean	9.9 ± 1.76	14.3 ± 1.49	12.6 ± 2.69

Sex: Female, Male
Sex: Female, Male(Participants)	6 to < 12 Years	≥ 12 to ≤ 16 Years	Total
Female	6	7	13
Male	3	7	10

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	6 to < 12 Years	≥ 12 to ≤ 16 Years	Total
White	6	10	16
Black or African American	3	4	7

Study locations

14 sites

Children's Hospital of Alabama
Birmingham, Alabama 35233, United States
Bayview Research Group, LLC
Paramount, California 90723, United States
Children's Hospital Colorado
Aurora, Colorado 80045, United States
Jackson Memorial Hospital
Miami, Florida 33136, United States
University of Kentucky
Lexington, Kentucky 40536, United States
Mercy Clinic Children's Cancer and Hematology Center
St. Louis, Missouri 63141, United States
New York University Langone Medical Center
New York, New York 10016, United States
Stony Brook University Hospital
Stony Brook, New York 11794, United States
Presbyterian Blume Pediatric Hematology & Oncology Clinic
Charlotte, North Carolina 28204, United States
Akron Children's Hospital
Akron, Ohio 44308, United States
The Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma 73104, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232, United States
Children's Medical Center of Dallas
Dallas, Texas 75235, United States
Schneider Children Medical Center of Israel
Petach Tikva, 49202, Israel

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01369615
Lead sponsor: Purdue Pharma LP
Responsible party: Sponsor
First posted: Jun 9, 2011
Start date: Oct 2011
Primary completion: Dec 2013
Completion: May 2014
Results posted: Jan 15, 2015
Last update: Sep 9, 2015

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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