Trial · NCT00765856
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
NCT00765856, Phase 3, Terminated, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2020-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects. Trials, record NCT00765856. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00765856
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
- NCT number
- NCT00765856
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 27 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Chronic Pain
- Interventions
- Oxymorphone ER
- First posted
- 2008-10-03
- Last updated
- 2020-12-16
- Results first posted
- 2020-12-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Safety population defined as all participants that took at least 1 dose of study medication. | mg | MEAN |
| SECONDARY | 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) | Safety population defined as all participants that took at least 1 dose of study medication. | Tablets | MEAN |
| SECONDARY | 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) | Safety population defined as all participants that took at least 1 dose of study medication. | mg | MEAN |
| SECONDARY | 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) | Safety population defined as all participants that took at least 1 dose of study medication. | Rescue doses/day | MEAN |
| SECONDARY | 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) | Safety population defined as all participants that took at least 1 dose of study medication. | Total number of doses | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose | Titration Period | 35.25 | Standard Deviation 11.955 | mg | |
| Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose | Maintenance Period | 39.11 | Standard Deviation 15.176 | mg | |
| Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken | Titration Period | 36.1 | Standard Deviation 15.63 | Tablets | |
| Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken | Maintenance Period | 162.7 | Standard Deviation 66.77 | Tablets | |
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose | Titration Period | 7.9 | Standard Deviation 3.01 | mg | |
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose | Maintenance Period | 5.5 | Standard Deviation 1.49 | mg | |
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues | Titration Period | 1.5 | Standard Deviation 0.45 | Rescue doses/day | |
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues | Maintenance Period | 1.1 | Standard Deviation 0.30 | Rescue doses/day | |
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses | Titration Period | 19.0 | Standard Deviation 15.36 | Total number of doses | |
| Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses | Maintenance Period | 17.4 | Standard Deviation 40.60 | Total number of doses |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Titration Period | STARTED | Oxymorphone ER | 27 | |
| Titration Period | COMPLETED | Oxymorphone ER | 24 | |
| Titration Period | NOT COMPLETED | Oxymorphone ER | 3 | |
| Maintenance Period | STARTED | Oxymorphone ER | 24 | |
| Maintenance Period | COMPLETED | Oxymorphone ER | 18 | |
| Maintenance Period | NOT COMPLETED | Oxymorphone ER | 6 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Titration Period | 6 | 27 | |
| other | Somnolence | Nervous system disorders | Maintenance Period | 0 | 24 | |
| other | Headache | Nervous system disorders | Titration Period | 3 | 27 | |
| other | Headache | Nervous system disorders | Maintenance Period | 2 | 24 | |
| other | Dizziness | Nervous system disorders | Titration Period | 3 | 27 | |
| other | Dizziness | Nervous system disorders | Maintenance Period | 1 | 24 | |
| other | Nausea | Gastrointestinal disorders | Titration Period | 2 | 27 | |
| other | Nausea | Gastrointestinal disorders | Maintenance Period | 1 | 24 | |
| other | Fatigue | General disorders | Titration Period | 1 | 27 | |
| other | Fatigue | General disorders | Maintenance Period | 2 | 24 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Titration Period | 0 | 27 |
| Total, all-cause mortality | Maintenance Period | 0 | 24 |
| Total, other adverse events | Titration Period | 15 | 27 |
| Total, other adverse events | Maintenance Period | 7 | 24 |
| Total, serious adverse events | Titration Period | 0 | 27 |
| Total, serious adverse events | Maintenance Period | 3 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Titration Period vs Maintenance Period: deaths from any cause | Trial comparisons |
| Titration Period vs Maintenance Period: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00765856
GET https://conductscience.org/api/trials/v1/NCT00765856/events?page=2