ClinicalTrials.gov record
Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
ClinicalTrials.gov ID: NCT01400139
Public ClinicalTrials.gov record NCT01400139. 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
An Open-label, Multicenter Study to Assess the Long -Term Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain
Study identification
- NCT ID
- NCT01400139
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Purdue Pharma LP
- Industry
- Enrollment
- 922 participants
Conditions and interventions
Conditions
Interventions
- Hydrocodone bitartrate q24h film-coated 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
- Jun 30, 2011
- Primary completion
- Jul 31, 2013
- Completion
- Sep 30, 2013
- Last update posted
- Mar 9, 2020
2011 – 2013
United States locations
- U.S. sites
- 98
- U.S. states
- 31
- U.S. cities
- 84
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance Clinical Research | Birmingham | Alabama | 35213 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Genova Clinical Research | Tucson | Arizona | 85704 | — |
| Quality of Life Medical & Research Center, LLC | Tucson | Arizona | 85712 | — |
| ACRI -Phase1, LLC | Anaheim | California | 92801-2417 | — |
| United Clinical Research Center, Inc. | Anaheim | California | 92804 | — |
| Med Center | Carmichael | California | 95608 | — |
| Research Center of Fresno, Inc. | Fresno | California | 93726 | — |
| TriWest Research Associates | La Mesa | California | 91942 | — |
| Torrance Clinical Research | Lomita | California | 90717 | — |
| Skyline Research, LLC | Long Beach | California | 90806 | — |
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | — |
| 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 | — |
| Meridien Research | Bradenton | Florida | 34208 | — |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Clinical Physiology Associates | Fort Myers | Florida | 33916 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| 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 | — |
| Renstar Medical Research | Ocala | Florida | 34471 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Peninsula Research, Inc. | Ormond Beach | Florida | 32174 | — |
| Gold Coast Research, LLC | Plantation | Florida | 33317 | — |
| 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 | — |
| 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 | Leawood | Kansas | 66211 | — |
| Community Research | Crestview Hills | Kentucky | 41017 | — |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | — |
| Louisiana Research Associates, Inc. | New Orleans | Louisiana | 70114 | — |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | — |
| MedVadis Research Corporation | Watertown | Massachusetts | 02472-3930 | — |
| Medical Research Associates, Inc. | Traverse City | Michigan | 49684 | — |
| 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 | — |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | — |
| Drug Trials America | Hartsdale | New York | 10530 | — |
| Research Across America | New York | New York | 10022 | — |
| 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 | — |
| Pennsylvania Research Institute | Bensalem | Pennsylvania | 19020 | — |
| 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 | — |
| Pain Research of Charleston | Charleston | South Carolina | 29406 | — |
| Radiant Research, Inc. | Greer | South Carolina | 29651 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| 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 | — |
| Lovelace Scientific Resources, Inc. | Austin | Texas | 78758 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| Heights Doctor's Clinic | Houston | Texas | 77008 | — |
| JVC Family Medicine | Houston | Texas | 77040 | — |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77098 | — |
| TEAM Research of Central Texas | Killeen | Texas | 76543 | — |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | — |
| 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 NCT01400139, 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 9, 2020 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01400139 live on ClinicalTrials.gov.