Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Public ClinicalTrials.gov record NCT01192295. 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, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children From Ages 6 to 16 Years Old, Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
Study identification
- NCT ID
- NCT01192295
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 155 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years 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
- Nov 2010 (Type not available)
- Primary completion
- Jul 2014 (Actual)
- Completion
- Jul 2014 (Actual)
- Last update posted
- Mar 23, 2020
2010 – 2014
United States locations
- U.S. sites
- 35
- U.S. states
- 22
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| University of South Alabama, Children's and Women's Hospital | Mobile | Alabama | 36604 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| LS Packard Children's Hospital | Palo Alto | California | 94304 | — |
| Bayview Research Group, LLC | Paramount | California | 90723 | — |
| Shriners Hospitals for Children Northern California | Sacramento | California | 95817 | — |
| The Children's Hospital | Aurora | Colorado | 80045 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Jackson Memorial Hospital/University of Miami | Miami | Florida | 33136 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| St. John's Mercy Medical Center | St Louis | Missouri | 63141 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | — |
| Presbyterian Blume Pediatric Hematology and Oncology Clinic | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 22710 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Department of Pediatrics, University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| The Children's Hospital at OUMC | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | — |
| Children's Medical Ctr of Dallas | Dallas | Texas | 75235 | — |
| Research Facility | The Woodlands | Texas | 77381 | — |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | — |
| Pediatric Hematology and Oncology, Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01192295, 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 Mar 23, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01192295 live on ClinicalTrials.gov.