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Completed Phase 3 Interventional Results available

Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

ClinicalTrials.gov ID: NCT01789970

Public ClinicalTrials.gov record NCT01789970. 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-Week, Randomized, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 30 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Patients With Chronic Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

Study identification

NCT ID
NCT01789970
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Industry
Enrollment
625 participants

Conditions and interventions

Conditions

Interventions

  • Hydrocodone ER Drug
  • Placebo 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
Feb 28, 2013
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014
Last update posted
Jun 4, 2017

2013 – 2014

United States locations

U.S. sites
87
U.S. states
27
U.S. cities
74
Facility City State ZIP Site status
Teva Investigational Site 10416 Anniston Alabama
Teva Investigational Site 10382 Birmingham Alabama
Teva Investigational Site 10403 Birmingham Alabama
Teva Investigational Site 10412 Birmingham Alabama
Teva Investigational Site 10426 Mobile Alabama
Teva Investigational Site 10436 Montgomery Alabama
Teva Investigational Site 10363 Phoenix Arizona
Teva Investigational Site 10366 Phoenix Arizona
Teva Investigational Site 10437 Tucson Arizona
Teva Investigational Site 10358 Anaheim California
Teva Investigational Site 10408 Bell Gardens California
Teva Investigational Site 10425 Carmichael California
Teva Investigational Site 10390 Cerritos California
Teva Investigational Site 10429 El Cajon California
Teva Investigational Site 10423 Escondido California
Teva Investigational Site 10740 Garden Grove California
Teva Investigational Site 10391 Huntington Park California
Teva Investigational Site 10422 La Jolla California
Teva Investigational Site 10413 Laguna Hills California
Teva Investigational Site 10442 Laguna Hills California
Teva Investigational Site 10370 Los Angeles California
Teva Investigational Site 10392 Sherman Oaks California
Teva Investigational Site 10398 Thousand Oaks California
Teva Investigational Site 10428 Torrance California
Teva Investigational Site 10361 Walnut Creek California
Teva Investigational Site 10441 Waterbury Connecticut
Teva Investigational Site 10369 DeLand Florida
Teva Investigational Site 10744 Edgewater Florida
Teva Investigational Site 10379 Fort Lauderdale Florida
Teva Investigational Site 10365 Jacksonville Florida
Teva Investigational Site 10445 Leesburg Florida
Teva Investigational Site 10362 Orlando Florida
Teva Investigational Site 10381 Ormond Beach Florida
Teva Investigational Site 12036 Pembroke Pines Florida
Teva Investigational Site 10357 Plantation Florida
Teva Investigational Site 10367 Royal Palm Beach Florida
Teva Investigational Site 10435 Royal Palm Beach Florida
Teva Investigational Site 10742 Sanford Florida
Teva Investigational Site 10432 Columbus Georgia
Teva Investigational Site 10383 Marietta Georgia
Teva Investigational Site 10385 Marietta Georgia
Teva Investigational Site 10444 Newnan Georgia
Teva Investigational Site 10431 Meridian Idaho
Teva Investigational Site 10743 Meridian Idaho
Teva Investigational Site 10411 Chicago Illinois
Teva Investigational Site 10418 Avon Indiana
Teva Investigational Site 10380 Evansville Indiana
Teva Investigational Site 10440 Newburgh Indiana
Teva Investigational Site 10375 Overland Park Kansas
Teva Investigational Site 10419 New Orleans Louisiana
Teva Investigational Site 10359 Shreveport Louisiana
Teva Investigational Site 10389 Fall River Massachusetts
Teva Investigational Site 10388 Bay City Michigan
Teva Investigational Site 10397 Biloxi Mississippi
Teva Investigational Site 10406 Hazelwood Missouri
Teva Investigational Site 10401 St Louis Missouri
Teva Investigational Site 10376 Omaha Nebraska
Teva Investigational Site 10396 Omaha Nebraska
Teva Investigational Site 10417 Henderson Nevada
Teva Investigational Site 10399 Las Vegas Nevada
Teva Investigational Site 10409 Berlin New Jersey
Teva Investigational Site 10439 Buffalo New York
Teva Investigational Site 10394 New York New York
Teva Investigational Site 10407 New York New York
Teva Investigational Site 10410 New York New York
Teva Investigational Site 10443 Raleigh North Carolina
Teva Investigational Site 10414 Winston-Salem North Carolina
Teva Investigational Site 10446 Oklahoma City Oklahoma
Teva Investigational Site 10415 Altoona Pennsylvania
Teva Investigational Site 10430 Duncansville Pennsylvania
Teva Investigational Site 10386 Mechanicsburg Pennsylvania
Teva Investigational Site 10373 Tipton Pennsylvania
Teva Investigational Site 10404 North Charleston South Carolina
Teva Investigational Site 10741 Spartanburg South Carolina
Teva Investigational Site 10405 Austin Texas
Teva Investigational Site 10364 Dallas Texas
Teva Investigational Site 10372 Dallas Texas
Teva Investigational Site 10395 Dallas Texas
Teva Investigational Site 10371 Houston Texas
Teva Investigational Site 12035 Houston Texas
Teva Investigational Site 10377 Lake Jackson Texas
Teva Investigational Site 10374 Plano Texas
Teva Investigational Site 10378 San Antonio Texas
Teva Investigational Site 10402 Salt Lake City Utah
Teva Investigational Site 10438 Roanoke Virginia
Teva Investigational Site 10420 Bellevue Washington
Teva Investigational Site 10433 Everett Washington

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 NCT01789970, 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

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01789970 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →