Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
Public ClinicalTrials.gov record NCT01428583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, 12-month, Open-label, Single-arm, Safety Study Of Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules In Subjects With Moderate To Severe Chronic Noncancer Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.
Study identification
- NCT ID
- NCT01428583
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 395 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2010
- Primary completion
- Apr 30, 2012
- Completion
- Apr 30, 2012
- Last update posted
- Nov 20, 2016
2010 – 2012
United States locations
- U.S. sites
- 32
- U.S. states
- 17
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | — |
| Drug Study Institute | Jupiter | Florida | 33458 | — |
| Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | 32174 | — |
| Peninsula Research, Inc. | Ormond Beach | Florida | 32174 | — |
| Accord Clinical Research | Port Orange | Florida | 32129 | — |
| Sarasota Pain Medicine Research | Sarasota | Florida | 34238 | — |
| Clinical Research of West Florida | Tampa | Florida | 33603 | — |
| Center for Prospective Outcome Studies, Inc. | Atlanta | Georgia | 30327 | — |
| Drug Studies America | Marietta | Georgia | 30060 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| The Pain Treatment Center of the Bluegrass | Lexington | Kentucky | 40503 | — |
| Commonwealth Biomedical Research | Madisonville | Kentucky | 42431 | — |
| Crossroads Research | Owings Mills | Maryland | 21117 | — |
| DM Clinical Research | Springfield | Massachusetts | 01103 | — |
| MAPS Applied Research Center | Edina | Minnesota | 55435 | — |
| Mid-South Anesthesia Consultants | Southaven | Mississippi | 38671 | — |
| Healthcare Research, LLC | Hazelwood | Missouri | 64042 | — |
| Montana Neuroscience Institute | Missoula | Montana | 59802 | — |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | — |
| Drug Trials America - New York | Hartsdale | New York | 10530 | — |
| New York Spine and Wellness Center | North Syracuse | New York | 13212 | — |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | — |
| Center for Clinical Research, LLC - Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| Columbus Clinical Research, Inc. | Columbus | Ohio | 43213 | — |
| Allegheny Pain Management, PC | Altoona | Pennsylvania | 16602 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| Benchmark Research - Fort Worth | Fort Worth | Texas | 76135 | — |
| Quality Research, Inc. | San Antonio | Texas | 78209 | — |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | — |
| Hypothetest, LLC | Roanoke | Virginia | 24018 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01428583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 20, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01428583 live on ClinicalTrials.gov.