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NCT01192295 · ClinicalTrials.gov registry record · Phase 3
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
A Phase 3 study of Pain, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 155
- Enrollment target
- 20
- Study locations
NCT01192295: Completed Phase 3 study of Pain, sponsored by Purdue Pharma.
NCT01192295 is a Phase 3 study of Pain that has completed, run by Purdue Pharma. The registered enrollment target is 155 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192295, a Phase 3 study of Pain, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 155 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.
Conditions Studied
Interventions
- DRUG Oxycodone HCl controlled-release tablets
Study Locations (20)
California
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital of Orange County - Orange
- LS Packard Children's Hospital - Palo Alto
- Bayview Research Group, LLC - Paramount
- Shriners Hospitals for Children Northern California - Sacramento
Florida
- Memorial Regional Hospital - Hollywood
- Jackson Memorial Hospital/University of Miami - Miami
- Tampa General Hospital - Tampa
Alabama
- Children's Hospital of Alabama - Birmingham
- University of South Alabama, Children's and Women's Hospital - Mobile
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- The Children's Hospital - Aurora
Connecticut
- Connecticut Children's Medical Center - Hartford
Delaware
- Alfred I. duPont Hospital for Children - Wilmington
Illinois
- Children's Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT01192295 record still lists
NCT01192295 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Oxycodone HCl controlled-release tablets is the first listed.
NCT01192295 names 20 study sites across 12 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01192295 about?
NCT01192295 is a clinical study titled "Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids". 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.
What is the current status of trial NCT01192295?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 155 participants. The study started on 2010-11. Estimated completion is 2014-07.
What conditions does trial NCT01192295 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT01192295?
The interventions under investigation include: Oxycodone HCl controlled-release tablets (DRUG).
Who is sponsoring clinical trial NCT01192295?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01192295 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01192295's enrollment target sits among peer trials
155 113th of 374 higher than 262 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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.
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