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NCT00465647 · ClinicalTrials.gov registry record · Phase 4
An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
A Phase 4 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 116
- Enrollment target
NCT00465647: Completed Phase 4 study, sponsored by Purdue Pharma.
NCT00465647 is a Phase 4 study that has completed, run by Purdue Pharma. The registered enrollment target is 116 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00465647, a Phase 4 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 116 participants
- Enrollment target
Study Summary
The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
Primary Outcome
Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study. Efficacy was based on Oral treatment only.
Interventions
- DRUG Hydromorphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
What the finished NCT00465647 record still lists
NCT00465647 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydromorphone is the first listed.
NCT00465647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00465647 about?
NCT00465647 is a clinical study titled "An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain". The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric s...
What is the current status of trial NCT00465647?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 116 participants. The study started on 2007-04. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00465647?
The interventions under investigation include: Hydromorphone (DRUG).
Who is sponsoring clinical trial NCT00465647?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00465647's enrollment target sits among peer trials
116 714th of 2000 higher than 1,283 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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