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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 is a Phase 4 study that has completed, run by Purdue Pharma. The registered enrollment target is 116 participants.
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.
Interventions
- DRUG Hydromorphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00465647
The ClinicalTrials.gov registry entry for NCT00465647 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hydromorphone is the first listed.
NCT00465647 reports 0 study locations.
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.
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