Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
Public ClinicalTrials.gov record NCT01115569. 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 Long-Term Open-Label Safety Study of Hydrocodone Bitartrate Controlled-Release Capsules With Flexible Dosing to Treat Subjects With Moderate to Severe Chronic Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.
Study identification
- NCT ID
- NCT01115569
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 424 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
- May 2010 (Type not available)
- Primary completion
- Jan 2012 (Actual)
- Completion
- Jan 2012 (Actual)
- Last update posted
- Nov 9, 2022
2010 – 2012
United States locations
- U.S. sites
- 50
- U.S. states
- 26
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| HOPE Research Institute, LLC | Phoenix | Arizona | 85050 | — |
| Cochise Clinical Research | Sierra Vista | Arizona | 85635 | — |
| Ortho Research | Little Rock | Arkansas | 72205 | — |
| Pain Institute of California | Bakersfield | California | 93311 | — |
| Providence Clinical Research | Burbank | California | 91505 | — |
| South Orange County Surgical Medical Group | Laguna Hills | California | 92653 | — |
| Scripps Clinic, Clinical Research | San Diego | California | 92128 | — |
| Mountain View Clinical Research, Inc. | Golden | Colorado | 80401 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | — |
| Gold Coast Research, LLC | Plantation | Florida | 33317 | — |
| Advanced Research Institute, Inc. | Trinity | Florida | 34655 | — |
| National Pain Research Institute, Inc. | Winter Park | Florida | 32789 | — |
| Best Clinical Research | Decatur | Georgia | 30034 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| Better Health Clinical Research, Inc | Newnan | Georgia | 30265 | — |
| Nautical Clinical Research, LLC | Boise | Idaho | 83702 | — |
| Suburban Clinical Research | Bolingbrook | Illinois | 60490 | — |
| International Clinical Research Institute, Inc. | Leawood | Kansas | 66211 | — |
| Clinical Trials Technology, Inc. | Prairie Village | Kansas | 66206 | — |
| Clinical Trials Managements, LLC | Mandeville | Louisiana | 70471 | — |
| Willis-Knighton Physician Network | Shreveport | Louisiana | 71101 | — |
| New England Center for Clinical Research, Internal Medicine and Cardiology Associates, LLC | Fall River | Massachusetts | 02720 | — |
| Infinity Medical Research, Inc. | North Dartmouth | Massachusetts | 02747 | — |
| Mid-South Anesthesia Consultants | Southaven | Mississippi | 38671 | — |
| Clinvest | Springfield | Missouri | 65807 | — |
| Mercy Health Research | St Louis | Missouri | 63141 | — |
| Research West, LLC | Kalispell | Montana | 59901 | — |
| Lovelace Scientific Resources, Inc. | Albuquerque | New Mexico | 87108 | — |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | — |
| New York University Pain Management Center | New York | New York | 10016 | — |
| The Center for Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | — |
| Valley Medical Group, PC | Centerville | Ohio | 45459 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Hometown Urgent Care and Research | Springfield | Ohio | 45504 | — |
| Hillcrest Clinical Research, Inc. | Oklahoma City | Oklahoma | 73119 | — |
| Memorial Clinical Research DBA Angelique Barreto, MD | Oklahoma City | Oklahoma | 73134 | — |
| Blair Medical Associates | Altoona | Pennsylvania | 16602 | — |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | — |
| New England Center for Clinical Research, Inc. | Cranston | Rhode Island | 02920 | — |
| Renaissance Clinical Research and Hypertension Clinic | Dallas | Texas | 75235 | — |
| The Clinical Research Center, LLC | Fort Worth | Texas | 76104 | — |
| Heights Doctors Clinic | Houston | Texas | 77008 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Quality Research, Inc. | San Antonio | Texas | 78209 | — |
| West Side Medical | Clinton | Utah | 84015 | — |
| Jean Brown Research | Salt Lake City | Utah | 84124 | — |
| Advanced Pain Management | Virginia Beach | Virginia | 23454 | — |
| 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 NCT01115569, 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 9, 2022 · 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 NCT01115569 live on ClinicalTrials.gov.