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NCT01160614 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients
A Phase 1 study of Opioid Analgesia, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 17
- Study locations
NCT01160614: Completed Phase 1 study of Opioid Analgesia, sponsored by Purdue Pharma.
NCT01160614 is a Phase 1 study of Opioid Analgesia that has completed, run by Purdue Pharma. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160614, a Phase 1 study of Opioid Analgesia, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 17
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Oxycodone hydrochloride controlled-release (ORF) tablets
Study Locations (17)
Other
- The Royal Children's Hospital - Parkville
- Helsinki University Central Hospital/Children and Adolescent Hospital - Helsinki
- Kuopio University Hospital/Operative Services and Intensive Care - Kuopio
- Waikato Clinical Research (2008) Ltd - Hamilton
Texas
- Children's Med Center of Dallas - Dallas
- Scott & White Memorial Hospital & Clinic - Temple
Arizona
- Maricopa Medical Center - Phoenix
Arkansas
- Arkansas Childrens Hospital - Little Rock
California
- LS Packard Children's Hospital - Palo Alto
Colorado
- The Children's Hospital Association - Aurora
Florida
- Research Facility - Miami
Michigan
- F3900 C.S. Mott Children's Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT01160614 record still lists
NCT01160614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Opioid Analgesia appearing as the primary indexed condition, and to 1 intervention - of which Oxycodone hydrochloride controlled-release (ORF) tablets is the first listed.
NCT01160614 lists 17 locations in 13 states (Other, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT01160614 about?
NCT01160614 is a clinical study titled "Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients". 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.
What is the current status of trial NCT01160614?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-07. Estimated completion is 2011-08.
What conditions does trial NCT01160614 study?
This clinical trial studies the following conditions: Opioid Analgesia.
What interventions are being tested in trial NCT01160614?
The interventions under investigation include: Oxycodone hydrochloride controlled-release (ORF) tablets (DRUG).
Who is sponsoring clinical trial NCT01160614?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01160614 being conducted?
This trial has 17 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01160614's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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