Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Public ClinicalTrials.gov record NCT00765856. 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 Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.
Study identification
- NCT ID
- NCT00765856
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 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
- Nov 16, 2008
- Primary completion
- Feb 21, 2010
- Completion
- Feb 21, 2010
- Last update posted
- Dec 15, 2020
2008 – 2010
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine | Little Rock | Arkansas | 72202 | — |
| Stanford University School of Medicine | Stanford | California | 94305 | — |
| The Children's Hospital | Aurora | Colorado | 80045 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | — |
| Tukoi Clinical Research | Miami | Florida | 34104 | — |
| St. Joseph's Children's Hospital of Tampa | Tampa | Florida | 33618 | — |
| Taylor Research, LLC | Marietta | Georgia | 30060 | — |
| Rehabilitation Associates of Indiana | Indianapolis | Indiana | 46250 | — |
| University of Louisville Reserach Foundation, Inc. | Louisville | Kentucky | 40202 | — |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Hershey Medical Center | Hershey | Pennsylvania | 17112 | — |
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 NCT00765856, 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 Dec 15, 2020 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00765856 live on ClinicalTrials.gov.