Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects

An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00765856

Enrollment

Registered

2008-10-03

Start date

2008-11-17

Completion date

2010-02-22

Last updated

2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Opioid tolerant, Pediatric, Male 6-17 years of age, Female 6-17 years of age, Pain, Non malignant, Malignant

Brief summary

Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental breakthrough pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.

Detailed description

An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Interventions

DRUGOxymorphone ER

Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period. Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent) * Weigh at least 50 kg * Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.

Exclusion criteria

* Have a life expectancy \<4 weeks * Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period * Have dysphagia or difficulty swallowing whole tablets * Have a previous exposure to oxymorphone * Have an ileostomy

Design outcomes

Primary

Measure	Time frame	Description
Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)	Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.

Secondary

Measure	Time frame	Description
Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)	Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)	Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)	Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)	Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Oxymorphone ER Open-label dose titration period of up to 4 weeks and open-label maintenance period of up to 12 weeks.	27
Total	27

Baseline characteristics

Characteristic	Oxymorphone ER
Age, Continuous	14.8 years STANDARD_DEVIATION 1.58
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	23 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	2 Participants
Sex: Female, Male Female	15 Participants
Sex: Female, Male Male	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 27	0 / 24
other Total, other adverse events	15 / 27	7 / 24
serious Total, serious adverse events	0 / 27	3 / 24

Outcome results

Primary

Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose

Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.