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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.

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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

FieldValue
Enrollment Target 116 participants
Start Date 2007-04
Est. Completion 2010-04
Phase Phase 4

Sponsor

Purdue Pharma

54 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.