A Phase 3 interventional study of Oxymorphone ER in Chronic Pain, sponsored by Endo Pharmaceuticals. Terminated at 13 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Endo Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Endo Pharmaceuticals is the lead sponsor of 100 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Oxymorphone 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
Also known as: Opana ER, Opana
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.
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken
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.
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose
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.
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues
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.
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses
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.
Time frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
| Milestone | Oxymorphone ER |
|---|---|
| Started | 27 |
| Completed | 24 |
| Not completed | 3 |
| Milestone | Oxymorphone ER |
|---|---|
| Started | 24 |
| Completed | 18 |
| Not completed | 6 |
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.
| mg | Titration Period | Maintenance Period |
|---|---|---|
| Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose | 35.25 ± 11.955 | 39.11 ± 15.176 |
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.
| Tablets | Titration Period | Maintenance Period |
|---|---|---|
| Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken | 36.1 ± 15.63 | 162.7 ± 66.77 |
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.
| mg | Titration Period | Maintenance Period |
|---|---|---|
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose | 7.9 ± 3.01 | 5.5 ± 1.49 |
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.
| Rescue doses/day | Titration Period | Maintenance Period |
|---|---|---|
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues | 1.5 ± 0.45 | 1.1 ± 0.30 |
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.
| Total number of doses | Titration Period | Maintenance Period |
|---|---|---|
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses | 19.0 ± 15.36 | 17.4 ± 40.60 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Titration Period | 0/27 (0%) | 0/27 (0%) | 15/27 (55.6%) |
| Maintenance Period | 0/24 (0%) | 3/24 (12.5%) | 7/24 (29.2%) |
| Event | Titration Period | Maintenance Period |
|---|---|---|
| Sickle cell anemia with crisisCongenital, familial and genetic disorders | 0/27 | 1/24 |
| Acute pancreatitisGastrointestinal disorders | 0/27 | 1/24 |
| Abdominal painGastrointestinal disorders | 0/27 | 1/24 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/27 | 1/24 |
| Increased alanine aminotransferaseInvestigations | 0/27 | 1/24 |
| Increased aspartate aminotransferaseInvestigations | 0/27 | 1/24 |
| Colitis ulcerativeGastrointestinal disorders | 0/27 | 1/24 |
| PouchitisGastrointestinal disorders | 0/27 | 1/24 |
| PainGeneral disorders | 0/27 | 1/24 |
| Event | Titration Period | Maintenance Period |
|---|---|---|
| SomnolenceNervous system disorders | 6/27 | 0/24 |
| HeadacheNervous system disorders | 3/27 | 2/24 |
| DizzinessNervous system disorders | 3/27 | 1/24 |
| FatigueGeneral disorders | 1/27 | 2/24 |
| DehydrationMetabolism and nutrition disorders | 0/27 | 2/24 |
| NauseaGastrointestinal disorders | 2/27 | 1/24 |
Safety Population
| Age, Continuous(years) | Oxymorphone ER |
|---|---|
| Mean | 14.8 ± 1.58 |
| Sex: Female, Male(Participants) | Oxymorphone ER |
|---|---|
| Female | 15 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Oxymorphone ER |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Oxymorphone ER |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 23 |
| White | 2 |
| More than one race | 1 |
| Unknown or Not Reported | 1 |
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Endo Pharmaceuticals