Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time
Public ClinicalTrials.gov record NCT01240863. 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-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain 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 efficacy of hydrocodone extended-release (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12.
Study identification
- NCT ID
- NCT01240863
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 391 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
- Nov 2010 (Type not available)
- Primary completion
- Aug 2011 (Actual)
- Completion
- Aug 2011 (Actual)
- Last update posted
- Jun 5, 2017
2010 – 2011
United States locations
- U.S. sites
- 73
- U.S. states
- 27
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Horizon Research Group LLC | Mobile | Alabama | 36608 | — |
| Radiant Research, Inc. | Chandler | Arizona | 85225 | — |
| Radiant Research, Inc. | Scottsdale | Arizona | 85251 | — |
| Radiant Research Inc. | Tucson | Arizona | 85710 | — |
| Physician Alliance Research Center | Anaheim | California | 92804 | — |
| Associated Pharmaceutical Research Center, Inc. | Buena Park | California | 90620 | — |
| Providence Clinical Research | Burbank | California | 91505 | — |
| Synergy Clinical Research | Escondido | California | 92025 | — |
| Research Center of Fresno, Inc. | Fresno | California | 93726 | — |
| Pacific Coast Pain Management Center | Laguna Hills | California | 92637 | — |
| South Orange County Surgical Medical Group | Laguna Hills | California | 92653 | — |
| Robert M. Karns, MD A Medical Corporation | Los Angeles | California | 90036 | — |
| Accelovance, Inc. | San Diego | California | 92108 | — |
| Radiant Research, Inc. | Santa Rosa | California | 95405 | — |
| Bayview Research Group, LLC | Valley Village | California | 91607 | — |
| Radiant Research, Inc | Denver | Colorado | 80239 | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| International Research Associates, LLC | Miami | Florida | 33183 | — |
| Compass Research | Orlando | Florida | 32806 | — |
| Radiant Research, Inc. | Pinellas Park | Florida | 33781 | — |
| Gold Coast Research LLC | Plantation | Florida | 33317 | — |
| Sarasota Pain Medicine Research LLC | Sarasota | Florida | 34238 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| Drug Studies America | Marietta | Georgia | 30060 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| Better Health Clinical Research, Inc. | Newnan | Georgia | 30265 | — |
| Millennium Pain Center | Bloomington | Illinois | 61701 | — |
| Medex Healthcare Research, Inc. | Chicago | Illinois | 60603 | — |
| Rehabilitation Associates of Indiana | Indianapolis | Indiana | 46250 | — |
| International Clinical Research, Inc. | Leawood | Kansas | 66211 | — |
| Community Research | Crestview | Kentucky | 41017 | — |
| The Pain Treatment Center of the Bluegrass | Lexington | Kentucky | 40503 | — |
| Horizon Research Group, LLC | Baton Rouge | Louisiana | 70809 | — |
| WK River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | — |
| MidAtlantic Pain Medicine Center | Pikesville | Maryland | 21208 | — |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | — |
| HealthCare Research | Florissant | Missouri | 63031 | — |
| Medex Healthcare Research Inc. | St Louis | Missouri | 63117 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | — |
| Advanced Pain Consultants | Voorhees Township | New Jersey | 08043 | — |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Radiant Research, Inc | Akron | Ohio | 44311 | — |
| Sterling Research Group, Ltd. | Cincinnati | Ohio | 45219 | — |
| Community Research, Inc | Cincinnati | Ohio | 45227 | — |
| Community Research, Inc | Cincinnati | Ohio | 45245 | — |
| Rapid Medical Research | Cleveland | Ohio | 44122 | — |
| Columbus Clinical Research | Columbus | Ohio | 43213 | — |
| SP Research | Oklahoma City | Oklahoma | 73112 | — |
| Pain Research of Oregon | Eugene | Oregon | 97401 | — |
| Summit Research Network Inc. | Portland | Oregon | 97210 | — |
| Brandywine Clinical Research | Downingtown | Pennsylvania | 19335 | — |
| Tipton Medical and Diagnostic Center | Tipton | Pennsylvania | 16684 | — |
| AMH Feasterville Family Health Care Center | Trevose | Pennsylvania | 19053 | — |
| Clinical Research Center of Reading | Wyomissing | Pennsylvania | 19610 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Radiant Research Inc. | Anderson | South Carolina | 29621 | — |
| Greenville Pharmaceutical Research | Greenville | South Carolina | 29615 | — |
| Radiant Research, Inc | Greer | South Carolina | 29651 | — |
| Trident Institute of Medical Research, LLC | North Charleston | South Carolina | 29406 | — |
| South Carolina Pharmaceutical Research | Spartanburg | South Carolina | 29303 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| Radiant Research Dallas | Dallas | Texas | 75231 | — |
| Renaissance Clinical Research & Hypertension of Texas, PLLC | Dallas | Texas | 75235 | — |
| Medstar Clinical Research | Houston | Texas | 77083 | — |
| Benchmark Research | San Angelo | Texas | 76904 | — |
| DCT-Sugarland, LLC | Sugar Land | Texas | 77478 | — |
| Hillcrest Family Health Centers | Waco | Texas | 76710 | — |
| Aspen Clinical Research, LLC | Orem | Utah | 84058 | — |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | — |
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 NCT01240863, 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 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01240863 live on ClinicalTrials.gov.