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Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
NCT01192295 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01192295 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01192295?
The interventions under investigation include: Oxycodone HCl controlled-release tablets (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01192295?
This trial is sponsored by Purdue Pharma, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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