ClinicalTrials.gov record
Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
ClinicalTrials.gov ID: NCT01452529
Public ClinicalTrials.gov record NCT01452529. 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, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Low Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen
Study identification
- NCT ID
- NCT01452529
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 905 participants
Conditions and interventions
Conditions
Interventions
- Hydrocodone bitartrate q24h film-coated tablets Drug
- Placebo to match hydrocodone bitartrate q24h tablets Drug
Drug
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
- Oct 2011 (Type not available)
- Primary completion
- Sep 2013 (Actual)
- Completion
- Oct 2013 (Actual)
- Last update posted
- Mar 10, 2020
2011 – 2013
United States locations
- U.S. sites
- 102
- U.S. states
- 32
- U.S. cities
- 86
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance Clinical Research | Birmingham | Alabama | 35213 | — |
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Redpoint Research | Phoenix | Arizona | 85029 | — |
| Genova Clinical Research | Tucson | Arizona | 85704 | — |
| Quality of Life Medical & Research Center, LLC | Tucson | Arizona | 85712 | — |
| Redpoint Research | Tucson | Arizona | 85712 | — |
| ACRI-Phase 1, LLC | Anaheim | California | 92801-2417 | — |
| Orange County Research Institute | Anaheim | California | 92801 | — |
| United Clinical Research Center, Inc. | Anaheim | California | 92804 | — |
| Research Center of Fresno, Inc. | Fresno | California | 93726 | — |
| TriWest Research Associates | La Mesa | California | 91942 | — |
| Torrance Clinical Research Institute Inc. | Lomita | California | 90717 | — |
| Skyline Research, LLC | Long Beach | California | 90806 | — |
| Center for Clinical Research, Inc. | Richmond | California | 94806 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Encompass Clinical Research | Spring Valley | California | 91978 | — |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | — |
| Orthopedic Research Institute | Boynton Beach | Florida | 33472 | — |
| Meridien Research | Bradenton | Florida | 34208 | — |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Florida Health Center | Fort Lauderdale | Florida | 33312 | — |
| Clinical Physiology Associates | Fort Myers | Florida | 33916 | — |
| AGA Clinical Trials | Hialeah | Florida | 33012 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32216 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Fidelity Clinical Research, Inc. | Lauderhill | Florida | 33319 | — |
| Neuroscience Consultants LLC | Miami | Florida | 33176 | — |
| International Research Associates, LLC | Miami | Florida | 33183 | — |
| Journey Research, Inc | Oldsmar | Florida | 34677 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Peninsula Research Inc. | Ormond Beach | Florida | 32174 | — |
| Advent Clinical Research Centers, Inc. | Pinellas Park | Florida | 33781 | — |
| Gold Coast Research, LLC | Plantation | Florida | 33317 | — |
| Sarasota Research, LLC | Sarasota | Florida | 34243 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| Southeast Regional Research Group | Columbus | Georgia | 31904 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| Taylor Research, LLC | Marietta | Georgia | 30060 | — |
| Better Health Clinical Research, Inc. | Newnan | Georgia | 30265 | — |
| Atlanta Knee and Shoulder Clinic, PC | Stockbridge | Georgia | 30281 | — |
| Illinois Center for Clinical Research | Chicago | Illinois | 60622 | — |
| Rehabilitation Associates of Indiana | Indianapolis | Indiana | 46250 | — |
| Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | 46383 | — |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | 50265 | — |
| ICRI | Overland Park | Kansas | 66210 | — |
| Community Research | Crestview Hills | Kentucky | 41017 | — |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | — |
| Louisiana Research Associates, Inc. | New Orleans | Louisiana | 70114 | — |
| IRC Clinics, Inc. | Towson | Maryland | 21204 | — |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | — |
| MedVadis Research Corporation | Watertown | Massachusetts | 02472-3930 | — |
| QUEST Research Institute | Bingham Farms | Michigan | 48025 | — |
| Medical Research Associates, Inc. | Traverse City | Michigan | 49684 | — |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | — |
| Medex Healthcare Research, Inc. | St Louis | Missouri | 63117 | — |
| Advance Clinical Research | St Louis | Missouri | 63128 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Quality Clinical Research | Omaha | Nebraska | 68114 | — |
| Advanced Biomedical Research of America | Las Vegas | Nevada | 89123 | — |
| Research Facility | Las Vegas | Nevada | 89144 | — |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | — |
| CRI Worldwide LLC | Willingboro | New Jersey | 08046 | — |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | — |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | — |
| Drug Trials America | Hartsdale | New York | 10530 | — |
| The Medical Research Network, LLC | New York | New York | 10128 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | — |
| PMG Research of Charlotte, LLC | Charlotte | North Carolina | 28209 | — |
| PMG Research of Wilmington LLC | Wilmington | North Carolina | 28401 | — |
| Clinical Trials of America, Inc. | Winston-Salem | North Carolina | 27103 | — |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Daystar Clinical Research, Inc. | Akron | Ohio | 44313 | — |
| IVA Research | Cincinnati | Ohio | 45245 | — |
| Community Research | Cincinnati | Ohio | 45255 | — |
| Bone Joint and Spine Surgeons, Inc. | Toledo | Ohio | 43623 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| Allegheny Pain Management, P.C. | Altoona | Pennsylvania | 16602 | — |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | — |
| Founders Research Corporation | Philadelphia | Pennsylvania | 19152 | — |
| Tipton Medical & Diagnostic Center | Tipton | Pennsylvania | 16684 | — |
| Hartwell Research Group | Anderson | South Carolina | 29621 | — |
| Radiant Research, Inc. | Greer | South Carolina | 29651 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| Comprehensive Pain Specialists, LLC | Hendersonville | Tennessee | 37075 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Heartland Medical, PC | New Tazewell | Tennessee | 37825 | — |
| HCCA Clinical Research Solutions | Smyrna | Tennessee | 37167 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| Heights Doctor's Clinic | Houston | Texas | 77008 | — |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Aspen Clinical Research | Orem | Utah | 84058 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| HypotheTest, LLC | Roanoke | Virginia | 24018 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Washington Center for Pain Management | Edmonds | Washington | 98026 | — |
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 NCT01452529, 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 Mar 10, 2020 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01452529 live on ClinicalTrials.gov.