ClinicalTrials.gov record
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
ClinicalTrials.gov ID: NCT01358526
Public ClinicalTrials.gov record NCT01358526. 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 Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Pain Due to Chronic Low Back Pain Who Require Around-the-clock Opioid Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.
Study identification
- NCT ID
- NCT01358526
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,095 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
- May 2011 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Nov 2012 (Actual)
- Last update posted
- Nov 11, 2015
2011 – 2012
United States locations
- U.S. sites
- 151
- U.S. states
- 36
- U.S. cities
- 126
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Orthopaedic Center, PC | Birmingham | Alabama | 35209 | — |
| Alliance Clinical Research | Birmingham | Alabama | 35213 | — |
| Winston Technology Research, LLC | Haleyville | Alabama | 35565 | — |
| Monte Sano Clinical Research, LLC | Huntsville | Alabama | 35801 | — |
| Research Facility | Mobile | Alabama | 36608 | — |
| Radiant Research, Inc. | Chandler | Arizona | 85224 | — |
| Dedicated Clinical Research | Phoenix | Arizona | 85020 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC | Phoenix | Arizona | 85050 | — |
| Quality of Life Medical & Research Center, LLC | Tucson | Arizona | 85712 | — |
| Ortho Surgeons | Little Rock | Arkansas | 72205 | — |
| Orange County Research Institute | Anaheim | California | 92801 | — |
| Physician Alliance Research Center | Anaheim | California | 92804 | — |
| Advanced Pain Research Institute | Arcadia | California | 91007 | — |
| Southbay Pharma Research | Buena Park | California | 90620 | — |
| Providence Clinical Research | Burbank | California | 91505 | — |
| Med Center | Carmichael | California | 95608 | — |
| Advanced Pain Management and Rehabilitation Medical Group, Inc. | Castro Valley | California | 94546 | — |
| Catalina Research Institute, LLC | Chino | California | 91710 | — |
| Synergy Clinical Research of Escondido | Escondido | California | 92025 | — |
| Valley Research | Fresno | California | 93720 | — |
| RX Clinical Research, Inc. | Garden Grove | California | 92843 | — |
| TriWest Research Associates | La Mesa | California | 91942 | — |
| Pacific Coast Pain Management Center | Laguna Hills | California | 92637 | — |
| South Orange County Surgical Medical Group | Laguna Hills | California | 92653 | — |
| Clinical Trials Research | Lincoln | California | 95648 | — |
| L.A. Pain and Wellness Institute | Los Angeles | California | 90017 | — |
| Newport Beach Clinical Research Associates, Inc. | Newport Beach | California | 92663 | — |
| Lotus Clinical Research | Pasadena | California | 91105 | — |
| Northern California Clinical Research Center | Redding | California | 96001 | — |
| Probe Clinical Research Corporation | Riverside | California | 92501 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Probe Clinical Research Corporation | Santa Ana | California | 92701 | — |
| Denver Internal Medicine Group | Denver | Colorado | 80209 | — |
| Front Range Clinical Research | Wheat Ridge | Colorado | 80033 | — |
| New England Research Associates, LLC | Trumbull | Connecticut | 06611 | — |
| Orthopedic Research Institute | Boynton Beach | Florida | 33472 | — |
| Coastal Orthopedics & Pain Management | Bradenton | Florida | 34208 | — |
| Southeast Clinical Research, LLC | Chiefland | Florida | 32626 | — |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | — |
| Omega Research Consultants, LLC | DeBary | Florida | 32713 | — |
| S & W Clinical Research | Fort Lauderdale | Florida | 33306 | — |
| Southeastern Integrated Medical, PL | Gainesville | Florida | 32607 | — |
| Health Care Family Rehab & Research Center | Hialeah | Florida | 33012 | — |
| Eastern Research, Inc. | Hialeah | Florida | 33013 | — |
| Southeast Clinical Research, LLC | Jacksonville | Florida | 32216 | — |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | — |
| Drug Study Institute | Jupiter | Florida | 33458 | — |
| Pharma Care Research, Inc. | Miami | Florida | 33144 | — |
| Advanced Pharma CR, LLC | Miami | Florida | 33175 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Peninsula Research, Inc. | Ormond Beach | Florida | 32174 | — |
| Sarasota Clinical Research, LLC | Sarasota | Florida | 34232 | — |
| Sarasota Pain Medicine Research | Sarasota | Florida | 34238 | — |
| Vita Research Solutions & Medical Center, Inc. | Tamarac | Florida | 33319 | — |
| Stedman Clinical Trials | Tampa | Florida | 33613 | — |
| Advanced Research Institute, Inc. | Trinity | Florida | 34655 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| National Pain Research Institute, LLC | Winter Park | Florida | 32789 | — |
| Independent Neurodiagnostic Clinic | Atlanta | Georgia | 30327 | — |
| In-Quest Medical Research, LLC | Duluth | Georgia | 30096 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| Research Facility | Marietta | Georgia | 30060 | — |
| Better Health Clinical Research, Inc. | Newnan | Georgia | 30265 | — |
| SouthCoast Medical Group | Savannah | Georgia | 31406 | — |
| Georgia Clinical Research, LLC | Snellville | Georgia | 30078 | — |
| The Pain Center | Boise | Idaho | 83702 | — |
| Clinical Investigation Specialists, Inc. | Gurnee | Illinois | 60031 | — |
| Destiny Clinical Research, LLC | Evansville | Indiana | 47714 | — |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | — |
| Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | 46383 | — |
| International Clinical Research Institute, Inc. | Leawood | Kansas | 66211 | — |
| Clinical Trials Technology, Inc. CTT Consultants, Inc. | Prairie Village | Kansas | 66206 | — |
| The Pain Treatment Center of the Bluegrass | Lexington | Kentucky | 40503 | — |
| Louisiana Research Associates, Inc. | New Orleans | Louisiana | 70114 | — |
| Research Facility | New Orleans | Louisiana | 70115 | — |
| Mid-Atlantic Medical Research Centers | Hollywood | Maryland | 20636 | — |
| MidAtlantic Pain Medicine Center | Pikesville | Maryland | 21208 | — |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | — |
| ActivMed Practices and Research | Haverhill | Massachusetts | 01830 | — |
| Medvadis Research Corporation | Watertown | Massachusetts | 02472-3930 | — |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | — |
| Great Lakes Family Care | Cadillac | Michigan | 49601 | — |
| Great Lakes Research Group, Inc. | Pinconning | Michigan | 48650 | — |
| Medex Healthcare Research, Inc. | St Louis | Missouri | 63117 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| Research Facility | Las Vegas | Nevada | 89109 | — |
| South Jersey Medical Associates, P.A. | Blackwood | New Jersey | 08012 | — |
| University of Medicine & Dentistry of New Jersey - School of Osteopathic Medicine (UMDNJ) | Stratford | New Jersey | 08084 | — |
| Five Towns Neuroscience Research/Five Towns Neurology | Cedarhurst | New York | 11516 | — |
| Long Island Gastrointestinal Research Group, LLP | Great Neck | New York | 11023 | — |
| Medex Healthcare Research, Inc. | New York | New York | 10022 | — |
| Research Across America | New York | New York | 10022 | — |
| Upstate Clinical Research Associates, LLC | Williamsville | New York | 14221 | — |
| Gaffney Health Services | Charlotte | North Carolina | 28205 | — |
| Box Arthritis & Rheumatology of the Carolinas, PLLC | Charlotte | North Carolina | 28210 | — |
| PharmQuest | Greensboro | North Carolina | 27408 | — |
| Peters Medical Research | High Point | North Carolina | 27262 | — |
| Plains Medical Clinic, LLC | Fargo | North Dakota | 58104 | — |
| Clinical Inquest Center Ltd. | Beavercreek | Ohio | 45432 | — |
| Community Research | Cincinnati | Ohio | 45227 | — |
| Columbus Clinical Research, Inc. | Columbus | Ohio | 43213 | — |
| Hometown Urgent Care and Research | Dayton | Ohio | 45432 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Hometown Urgent Care and Research | Springfield | Ohio | 45504 | — |
| J L Clinical Research | Tiffin | Ohio | 44883 | — |
| Bone Joint and Spine Surgeons, Inc. | Toledo | Ohio | 43623 | — |
| Pharmacotherapy Research Associates, Inc. | Zanesville | Ohio | 43701 | — |
| Neuropsychiatric Center and NPC Research | Oklahoma City | Oklahoma | 73109-3834 | — |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | — |
| Paradigm Research Professionals, LLC | Oklahoma City | Oklahoma | 73112 | — |
| Bend Memorial Clinic | Bend | Oregon | 97701 | — |
| Pain Consultants of Oregon | Eugene | Oregon | 97401 | — |
| Willamette Valley Clinical Studies | Eugene | Oregon | 97404 | — |
| Sunstone Medical Research, LLC | Medford | Oregon | 97504 | — |
| Allegheny Pain Management, PC | Altoona | Pennsylvania | 16602 | — |
| Paramount Clinical Research | Bridgeville | Pennsylvania | 15017 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | — |
| Central Pennsylvania Clinical Research | Mechanicsburg | Pennsylvania | 17055 | — |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | — |
| Dairyland Medical Center | Red Lion | Pennsylvania | 17356 | — |
| New England Center for Clinical Research, Inc | Cranston | Rhode Island | 02920 | — |
| Hartwell Research Group, LLC | Anderson | South Carolina | 29621 | — |
| Greenville Pharmaceutical Research, Inc. | Greenville | South Carolina | 29615 | — |
| Internal Medicine of Greer | Greer | South Carolina | 29650 | — |
| Meridian Clinical Research | Dakota Dunes | South Dakota | 57049 | — |
| Health Concepts Wellness Center | Rapid City | South Dakota | 57702 | — |
| Integrity Clinical Research, LLC | Huntingdon | Tennessee | 38344 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| Austin Center for Clinical Research | Austin | Texas | 78756 | — |
| Corpus Christi Pain Medicine | Corpus Christi | Texas | 78415 | — |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | — |
| Pineloch Medical Clinic | Houston | Texas | 77062 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Southwest Clinical Trials | Houston | Texas | 77074 | — |
| Protenium Clinical Research, LLC | Hurst | Texas | 76054 | — |
| TEAM Research of Central Texas | Killeen | Texas | 76543 | — |
| West Texas Medical Associates | San Angelo | Texas | 76904 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Research Facility | Bountiful | Utah | 84010 | — |
| Summit Pain Management | Murray | Utah | 84107 | — |
| Alpine Medical Group | Salt Lake City | Utah | 84102 | — |
| Highland Clinical Research | Salt Lake City | Utah | 84124 | — |
| Virginia Research Center | Midlothian | Virginia | 23114 | — |
| Hilltop Medical Center | Virginia Beach | Virginia | 23454 | — |
| Independence Family Medicine | Virginia Beach | Virginia | 23455 | — |
| Universal Research Group | Tacoma | Washington | 98405 | — |
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 NCT01358526, 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 11, 2015 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01358526 live on ClinicalTrials.gov.