Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain. Patients may be opioid-naïve or opioid-experienced.
Study identification
- NCT ID
- NCT01789970
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 625 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
- Mar 2013 (Type not available)
- Primary completion
- Feb 2014 (Actual)
- Completion
- Feb 2014 (Actual)
- Last update posted
- Jun 5, 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 5, 2017 · Synced Oct 19, 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 NCT01789970 live on ClinicalTrials.gov.