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Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain
NCT00226421 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in opioid-experienced patients with chronic low back pain.
Conditions Studied
Interventions
- DRUG Oxymorphone Extended Release
Study Locations (20)
Florida
- Radiant Research — Daytona Beach
- University Clinical Research — DeLand
- LCFP Inc. — Fort Myers
- Century Clinical Research — Holly Hill
- Ocala Rheumatology Research Center — Ocala
- The Arthritis Center — Palm Harbor
- Radiant Research — Pinellas Park
- Park Place Therapeutic Center — Plantation
Arizona
- Phoenix Center for Clinical Research — Phoenix
- Arizona Research — Phoenix
Georgia
- Comprehensive Neurology Specialists — Atlanta
- Comprehensive Neuroscience — Atlanta
Missouri
- Research Medical Center — Kansas City
- Radiant Research — St Louis
Alabama
- Southern Drug Research — Hueytown
Colorado
- Express Care Clinical Research — Colorado Springs
Delaware
- Glasgow Family Practice — Newark
Illinois
- Pain Specialists of Greater Chicago — Burr Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2004-10 |
| Est. Completion | 2005-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00226421
The ClinicalTrials.gov registry entry for NCT00226421 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 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo Pharmaceuticals, which has 23 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 Chronic Pain appearing as the primary indexed condition, and to 1 intervention — of which Oxymorphone Extended Release 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: NCT00226421 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Arizona, Georgia. 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 NCT00226421 about?
NCT00226421 is a clinical study titled "Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain". The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in opioid-experienced patients with chronic low back pain.
What is the current status of trial NCT00226421?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2004-10. Estimated completion is 2005-08.
What conditions does trial NCT00226421 study?
This clinical trial studies the following conditions: Chronic 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 NCT00226421?
The interventions under investigation include: Oxymorphone Extended Release (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00226421?
This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00226421 being conducted?
This trial has 20 study locations across Alabama, Arizona, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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