Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00765856 · ClinicalTrials.gov registry record · Phase 3
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 27
- Enrollment target
NCT00765856: Clinical Trial Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT00765856 is a Phase 3 study that was terminated before completion, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 27 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00765856, a Phase 3 study, was terminated before completion, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Oxymorphone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2008-11-17 |
| Est. Completion | 2010-02-22 |
| Phase | Phase 3 |
Why NCT00765856 stopped before completion
NCT00765856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Oxymorphone ER is the first listed.
NCT00765856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00765856 about?
NCT00765856 is a clinical study titled "Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects". 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...
What is the current status of trial NCT00765856?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2008-11-17. Estimated completion is 2010-02-22.
What interventions are being tested in trial NCT00765856?
The interventions under investigation include: Oxymorphone ER (DRUG).
Who is sponsoring clinical trial NCT00765856?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00765856's enrollment target sits among peer trials
27 1936th of 2000 higher than 64 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00912041 · 27 participants · NA
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
- NCT02847559 · 27 participants · Phase 2
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
- NCT03380195 · 27 participants · NA
Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness
- NCT03384238 · 27 participants · Phase 1
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI