An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
Public ClinicalTrials.gov record NCT00465647. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Open-label, Dose Titration Study Pharmacokinetics/Pharmacodynamics, Safety, and Efficacy of Hydromorphone Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00465647
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 116 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 28 Days to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2007 (Type not available)
- Primary completion
- May 2009 (Actual)
- Completion
- Apr 2010 (Actual)
- Last update posted
- Nov 18, 2015
2007 – 2010
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Children's Hospital of Orange County - Pediatric Subspecialty | Orange | California | 92868 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| The Children's Hospital | Aurora | Colorado | 80218 | — |
| Yale-New Haven Children's Hospital | New Haven | Connecticut | 06510 | — |
| Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Saint Louis University - Department of Neurology and Psychiatry | St Louis | Missouri | 63104 | — |
| The University of North Carolina - CH | Chapel Hill | North Carolina | 27599-7221 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Children's Medical Center | Dallas | Texas | 75235 | — |
| Texas Children's Hospital / Baylor College of Medicine | Houston | Texas | 77030 | — |
| The University of Texas, Health Sciences Center at Houston | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00465647, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 18, 2015 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00465647 live on ClinicalTrials.gov.