Trial Outcomes & Findings for Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects (NCT NCT00765856)
NCT ID: NCT00765856
Last Updated: 2020-12-16
Results Overview
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.
TERMINATED
PHASE3
27 participants
Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
2020-12-16
Participant Flow
Participant milestones
| Measure |
Oxymorphone ER
Oxymorphone ER dosage was adjusted by investigator during the titration period. Study was terminated early by the Sponsor.
|
|---|---|
|
Titration Period
STARTED
|
27
|
|
Titration Period
COMPLETED
|
24
|
|
Titration Period
NOT COMPLETED
|
3
|
|
Maintenance Period
STARTED
|
24
|
|
Maintenance Period
COMPLETED
|
18
|
|
Maintenance Period
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Baseline characteristics by cohort
| Measure |
Oxymorphone ER
n=27 Participants
Open-label dose titration period of up to 4 weeks and open-label maintenance period of up to 12 weeks.
|
|---|---|
|
Age, Continuous
|
14.8 years
STANDARD_DEVIATION 1.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)Population: Safety population defined as all participants that took at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Titration Period
n=27 Participants
Open-label dose titration period of up to 4 weeks
|
Maintenance Period
n=24 Participants
Open-label maintenance period of up to 12 weeks
|
|---|---|---|
|
Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose
|
35.25 mg
Standard Deviation 11.955
|
39.11 mg
Standard Deviation 15.176
|
SECONDARY outcome
Timeframe: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)Population: Safety population defined as all participants that took at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Titration Period
n=27 Participants
Open-label dose titration period of up to 4 weeks
|
Maintenance Period
n=24 Participants
Open-label maintenance period of up to 12 weeks
|
|---|---|---|
|
Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken
|
36.1 Tablets
Standard Deviation 15.63
|
162.7 Tablets
Standard Deviation 66.77
|
SECONDARY outcome
Timeframe: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)Population: Safety population defined as all participants that took at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Titration Period
n=25 Participants
Open-label dose titration period of up to 4 weeks
|
Maintenance Period
n=24 Participants
Open-label maintenance period of up to 12 weeks
|
|---|---|---|
|
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose
|
7.9 mg
Standard Deviation 3.01
|
5.5 mg
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)Population: Safety population defined as all participants that took at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Titration Period
n=25 Participants
Open-label dose titration period of up to 4 weeks
|
Maintenance Period
n=24 Participants
Open-label maintenance period of up to 12 weeks
|
|---|---|---|
|
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues
|
1.5 Rescue doses/day
Standard Deviation 0.45
|
1.1 Rescue doses/day
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)Population: Safety population defined as all participants that took at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Titration Period
n=25 Participants
Open-label dose titration period of up to 4 weeks
|
Maintenance Period
n=24 Participants
Open-label maintenance period of up to 12 weeks
|
|---|---|---|
|
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses
|
19.0 Total number of doses
Standard Deviation 15.36
|
17.4 Total number of doses
Standard Deviation 40.60
|
Adverse Events
Titration Period
Maintenance Period
Serious adverse events
| Measure |
Titration Period
n=27 participants at risk
Open-label dose titration period of up to 4 weeks
|
Maintenance Period
n=24 participants at risk
Open-label maintenance period of up to 12 weeks plus 30 days post-last dose
|
|---|---|---|
|
Congenital, familial and genetic disorders
Sickle cell anemia with crisis
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Investigations
Increased alanine aminotransferase
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Investigations
Increased aspartate aminotransferase
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Gastrointestinal disorders
Pouchitis
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
General disorders
Pain
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
Other adverse events
| Measure |
Titration Period
n=27 participants at risk
Open-label dose titration period of up to 4 weeks
|
Maintenance Period
n=24 participants at risk
Open-label maintenance period of up to 12 weeks plus 30 days post-last dose
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
22.2%
6/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
0.00%
0/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
8.3%
2/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Nervous system disorders
Dizziness
|
11.1%
3/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Gastrointestinal disorders
Nausea
|
7.4%
2/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
4.2%
1/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
General disorders
Fatigue
|
3.7%
1/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
8.3%
2/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
8.3%
2/24 • First dosing up to 30 days after the last dose of study medication, approximately 20 weeks (titration period of up to 4 weeks, the maintenance period of up to 12 weeks and 30 days post-last dose).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place