Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time
Public ClinicalTrials.gov record NCT01223365. 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 12-Month, Open-Label Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours in Patients Who Require Opioid Treatment for an Extended Period of Time
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.
Study identification
- NCT ID
- NCT01223365
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 330 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 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
- Oct 2010 (Type not available)
- Primary completion
- Sep 2012 (Actual)
- Completion
- Sep 2012 (Actual)
- Last update posted
- Jun 5, 2017
2010 – 2012
United States locations
- U.S. sites
- 54
- U.S. states
- 25
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Horizon Research Group, LLC | Mobile | Alabama | — | — |
| Physician Alliance Research Center | Anaheim | California | — | — |
| Adam D. Karns, MD | Beverly Hills | California | — | — |
| Associated Pharmaceutical Research Center, Inc. | Buena Park | California | — | — |
| Providence Clinical Research | Burbank | California | — | — |
| Research Center of Fresno, Inc. | Fresno | California | — | — |
| Pacific Coast Pain Management Center | Laguna Hills | California | — | — |
| South Orange County Surgical Medical Group | Laguna Hills | California | — | — |
| Accelovance, Inc. | San Diego | California | — | — |
| Bayview Research Group, LLC | Valley Village | California | — | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | — | — |
| Avail Clinical Research, LLC | DeLand | Florida | — | — |
| Compass Research, LLC | Orlando | Florida | — | — |
| Sarasota Pain Medicine Research LLC | Sarasota | Florida | — | — |
| Gold Coast Research LLC | Weston | Florida | — | — |
| Drug Studies America | Marietta | Georgia | — | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | — | — |
| Taylor Research, LLC | Marietta | Georgia | — | — |
| Better Health Clinical Research, Inc. | Newnan | Georgia | — | — |
| Millennium Pain Center | Bloomington | Illinois | — | — |
| Rehabilitation Associates of Indiana | Indianapolis | Indiana | — | — |
| International Clinical Research, Inc. | Overland Park | Kansas | — | — |
| Community Research | Crestview Hills | Kentucky | — | — |
| Willis Knighton River Cities Clinical Research Center | Shreveport | Louisiana | — | — |
| MidAtlantic Pain Medicine Center | Pikesville | Maryland | — | — |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | — | — |
| HealthCare Research | Florissant | Missouri | — | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | — | — |
| Meridian Clinical Research | Omaha | Nebraska | — | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | — | — |
| Advanced Pain Consultants | Voorhees Township | New Jersey | — | — |
| Upstate Clinical Research Associates | Williamsville | New York | — | — |
| Wake Research Associates | Raleigh | North Carolina | — | — |
| Sterling Research Group, Ltd. | Cincinnati | Ohio | — | — |
| Columbus Clinical Research | Columbus | Ohio | — | — |
| SP Research | Oklahoma City | Oklahoma | — | — |
| Pain Research of Oregon | Eugene | Oregon | — | — |
| Summit Research Network Inc. | Portland | Oregon | — | — |
| Brandywine Clinical Research | Downingtown | Pennsylvania | — | — |
| AMH Feasterville Family Health Care Center | Feasterville-Trevose | Pennsylvania | — | — |
| Tipton Medical and Diagnostic Center | Tipton | Pennsylvania | — | — |
| Clinical Research Center of Reading, LLP | West Reading | Pennsylvania | — | — |
| Omega Medical Research | Warwick | Rhode Island | — | — |
| Greenville Pharmaceutical Research | Greenville | South Carolina | — | — |
| Trident Institute of Medical Research, LLC | North Charleston | South Carolina | — | — |
| S. Carolina Pharmaceutical Research | Spartanburg | South Carolina | — | — |
| KRK Medical Research | Dallas | Texas | — | — |
| Radiant Research | Dallas | Texas | — | — |
| Renaissance Clinical Research & Hypertension of Texas, PLLC | Dallas | Texas | — | — |
| Medstar Clinical Research | Houston | Texas | — | — |
| Benchmark Research | San Angelo | Texas | — | — |
| DCT-Sugarland, LLC dba Discovery Clinical Trials | Sugar Land | Texas | — | — |
| Hillcrest Family Health Centers | Waco | Texas | — | — |
| Aspen Clinical Research, LLC | Orem | Utah | — | — |
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 NCT01223365, 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 Jun 5, 2017 · Synced Oct 27, 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 NCT01223365 live on ClinicalTrials.gov.