Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients
Public ClinicalTrials.gov record NCT01160614. 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 Study to Characterize the Pharmacokinetics and Safety of Oxycodone Hydrochloride q12h Controlled-Release (ORF) Tablets in Pediatric Patients Aged 6 to 16 Years Inclusive, Who Require Opioid Analgesia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to characterize the pharmacokinetics (PK) of single-dose ORF tablets in pediatric patients aged 6 to 16 years, inclusive.
Study identification
- NCT ID
- NCT01160614
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 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
- Jun 30, 2010
- Primary completion
- Jul 31, 2011
- Completion
- Jul 31, 2011
- Last update posted
- Oct 14, 2012
2010 – 2011
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Maricopa Medical Center | Phoenix | Arizona | 85008 | — |
| Arkansas Childrens Hospital | Little Rock | Arkansas | 72202-3591 | — |
| LS Packard Children's Hospital | Palo Alto | California | 94304 | — |
| The Children's Hospital Association | Aurora | Colorado | 80045 | — |
| Research Facility | Miami | Florida | 33136 | — |
| F3900 C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| The Children's Hospital at OUMC | Oklahoma City | Oklahoma | 73104-5070 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Children's Med Center of Dallas | Dallas | Texas | 75235 | — |
| Scott & White Memorial Hospital & Clinic | Temple | Texas | 76508 | — |
| University of Washington School of Medicine - Harborview Medical Center | Seattle | Washington | 98104-2420 | — |
| 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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01160614, 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 Oct 14, 2012 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01160614 live on ClinicalTrials.gov.