Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Public ClinicalTrials.gov record NCT00801398. 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
An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40). This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
Study identification
- NCT ID
- NCT00801398
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 58 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 16, 2009
- Primary completion
- Apr 17, 2011
- Completion
- Apr 17, 2011
- Last update posted
- Feb 26, 2019
2009 – 2011
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Stanford University School of Medicine | Stanford | California | 94305 | — |
| The Children's Hospital | Aurora | Colorado | 80045 | — |
| Children's Research Institute | Washington D.C. | District of Columbia | 20010 | — |
| St. Joseph's Children's Hospital of Tampa | Tampa | Florida | 33607 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| The Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| University of Washington | Seattle | Washington | 98104 | — |
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 NCT00801398, 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 Feb 26, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00801398 live on ClinicalTrials.gov.