ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01223365

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.

ClinicalTrials.gov public records Last synced May 17, 2026, 6:21 AM EDT

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

Study identification

NCT ID
NCT01223365
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Industry
Enrollment
330 participants

Conditions and interventions

Conditions

Interventions

  • Hydrocodone ER Drug

Drug

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
Sep 30, 2010
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012
Last update posted
Jun 4, 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 4, 2017 · Synced May 17, 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 protocol, eligibility criteria, and contact information for NCT01223365 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →