Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
Public ClinicalTrials.gov record NCT01922739. 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 6-Month, Open-Label, Extension Study to Evaluate the 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 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.
This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe chronic low back pain who require continuous opioid treatment for an extended period of time. To be eligible for Study 3104, patients were required to have completed the entire double blind treatment period on study drug (either placebo or hydrocodone bitartrate ER tablets) through week 12 of Study 3103 (NCT01789970) and to have met the entry criteria for Study 3104.
Study identification
- NCT ID
- NCT01922739
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 182 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
- Jul 2013 (Type not available)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Aug 2014 (Actual)
- Last update posted
- Nov 9, 2021
2013 – 2014
United States locations
- U.S. sites
- 61
- U.S. states
- 23
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 10391 | Huntington Park | 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 10369 | DeLand | 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 10357 | Plantation | Florida | — | — |
| Teva Investigational Site 10435 | Royal Palm Beach | 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 10440 | Newburgh | Indiana | — | — |
| 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 10399 | Las Vegas | Nevada | — | — |
| Teva Investigational Site 10409 | Berlin | New Jersey | — | — |
| Teva Investigational Site 10439 | Buffalo | New York | — | — |
| Teva Investigational Site 10410 | New York | New York | — | — |
| Teva Investigational Site 10414 | Winston-Salem | North Carolina | — | — |
| Teva Investigational Site 10446 | Oklahoma City | Oklahoma | — | — |
| Teva Investigational Site 10430 | Duncansville | Pennsylvania | — | — |
| Teva Investigational Site 10386 | Mechanicsburg | Pennsylvania | — | — |
| Teva Investigational Site 10373 | Tipton | Pennsylvania | — | — |
| Teva Investigational Site 10405 | Austin | Texas | — | — |
| Teva Investigational Site 10364 | Dallas | Texas | — | — |
| Teva Investigational Site 10372 | Dallas | Texas | — | — |
| Teva Investigational Site 10371 | 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 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 NCT01922739, 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 Nov 9, 2021 · 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 NCT01922739 live on ClinicalTrials.gov.