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NCT01210352 · ClinicalTrials.gov registry record · Phase 3
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
NCT01210352: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT01210352 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01210352, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain in pediatric subjects. This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Primary Outcome
Faces Pain Scale-Revised (FPS-R) was used for the 6 to ≤ 12 years age group, (0 = no pain and 10 = very much pain). Face, Legs, Activity, Cry, and Consolability (FLACC) behavior measurement was used for the 2 years to \< 6 years and 0 years to \< 2 years age groups, (0 = no pain and 10 = very much pain).
Interventions
- DRUG oxymorphone HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2010-12-13 |
| Est. Completion | 2017-10-06 |
| Phase | Phase 3 |
What the finished NCT01210352 record still lists
NCT01210352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which oxymorphone HCl is the first listed.
NCT01210352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01210352 about?
NCT01210352 is a clinical study titled "Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects". The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain in pediatric subjects. This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes ...
What is the current status of trial NCT01210352?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2010-12-13. Estimated completion is 2017-10-06.
What interventions are being tested in trial NCT01210352?
The interventions under investigation include: oxymorphone HCl (DRUG).
Who is sponsoring clinical trial NCT01210352?
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 NCT01210352's enrollment target sits among peer trials
61 1803rd of 2000 higher than 197 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
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