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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00765856
The ClinicalTrials.gov registry entry for NCT00765856 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oxymorphone ER is the first listed.
NCT00765856 reports 0 study locations.
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.
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