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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01192295
The ClinicalTrials.gov registry entry for NCT01192295 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (49% lower). The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.