Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
Public ClinicalTrials.gov record NCT01081912. 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 Trial to Evaluate the Efficacy, Tolerability and Safety of Hydrocodone Bitartrate Controlled-Release Capsules in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
Study identification
- NCT ID
- NCT01081912
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 510 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Mar 2010 (Type not available)
- Primary completion
- Oct 2011 (Actual)
- Completion
- Oct 2011 (Actual)
- Last update posted
- Dec 8, 2022
2010 – 2011
United States locations
- U.S. sites
- 51
- U.S. states
- 29
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Clopton Clinic | Jonesboro | Arkansas | 72401 | — |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Neuro-Pain Medical Center, Inc. | Fresno | California | 93710 | — |
| Pacific Coast Pain Management Center | Laguna Hills | California | 92637 | — |
| Clinicos, LLC | Colorado Springs | Colorado | 80904 | — |
| Interwest Rehabilitation, LLC | Littleton | Colorado | 80122 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | — |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | — |
| Peninsula Research, Inc. | Ormond Beach | Florida | 32174 | — |
| Gold Coast Research | Plantation | Florida | 33317 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| Perimeter Institute for Clinical Research, Inc. | Atlanta | Georgia | 30338 | — |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| Georgia Clinical Research | Snellville | Georgia | 30078 | — |
| Suburban Clinical Research | Chicago | Illinois | 60490 | — |
| Destiny Clinical Research, LLC | Evansville | Indiana | 47714 | — |
| Integrated Clinical Trials Services, Inc. | West Des Moines | Iowa | 50265 | — |
| International Clinical Research Institute | Leawood | Kansas | 66211 | — |
| Clinical Trials Technology, Inc | Prairie Village | Kansas | 66206 | — |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | — |
| Clinical Trials Management | Metairie | Louisiana | 70006 | — |
| Best Clinical Trials, LLC | New Orleans | Louisiana | 70115 | — |
| River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | — |
| NECCR Internal Medicine & Cardiology Associates, LLC | Fall River | Massachusetts | 02720 | — |
| Center for Clinical Trials | Biloxi | Mississippi | 39531 | — |
| Research West, LLC | Kalispell | Montana | 59901 | — |
| Office of Danka Michaels, MD | Las Vegas | Nevada | 89128 | — |
| South Jersey Medical Associates | Blackwood | New Jersey | 08012 | — |
| CRI Worldwide, LLC | Willingboro | New Jersey | 08046 | — |
| Five Towns Neuroscience Research | Cedarhurst | New York | 11516 | — |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | — |
| Center for Clinical Research LLC | Winston-Salem | North Carolina | 27103 | — |
| IVA Research | Cincinnati | Ohio | 45245 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Neuropsychiatric Research Center | Oklahoma City | Oklahoma | 73109 | — |
| Brandywine Clinical Research | Downingtown | Pennsylvania | 19335 | — |
| Feasterville Family Health Care Center | Feasterville | Pennsylvania | 19053 | — |
| New England Center for Clinical Research | Cranston | Rhode Island | 02920 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| Integrity Clinical Research, LLC | Milan | Tennessee | 38358 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Innovative Clinical Trials | San Antonio | Texas | 78229 | — |
| Invisions Consultants, LLC | San Antonio | Texas | 78229 | — |
| Clinical Trial Network | Spring | Texas | 77386 | — |
| Advanced Research Institute | Ogden | Utah | 84405 | — |
| Hypothe Test, LLC | Roanoke | Virginia | 24018 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
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 NCT01081912, 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 Dec 8, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01081912 live on ClinicalTrials.gov.