Long-term Open-Label Safety Study to Evaluate EN3409
Public ClinicalTrials.gov record NCT01755546. 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 Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Time
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.
Study identification
- NCT ID
- NCT01755546
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 304 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 30, 2012
- Primary completion
- Sep 30, 2014
- Completion
- Oct 31, 2014
- Last update posted
- Oct 17, 2018
2012 – 2014
United States locations
- U.S. sites
- 57
- U.S. states
- 22
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | — |
| Horizon Research Group, Inc | Mobile | Alabama | 36608 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Global Research, LLC | Anaheim | California | 92804 | — |
| Synergy Clinical Research Center of Escondido | Escondido | California | 92025 | — |
| RX Clinical Research, Inc. | Garden Grove | California | 92843 | — |
| Long Beach Center for Clinical Research | Long Beach | California | 90807 | — |
| Adam D. Karns, MD | Los Angeles | California | 90036 | — |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | — |
| Century Clinical Research, Inc. | Daytona Beach | Florida | 32117 | — |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Florida Health Center | Fort Lauderdale | Florida | 33312 | — |
| Eastern Research, Inc. | Hialeah | Florida | 33013 | — |
| Southeast Clinical Research, LLC | Jacksonville | Florida | 32216 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Research Centers of America, LLC | Oakland Park | Florida | 33334 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Ribo Research LLC DBA Peninsula Research | Ormond Beach | Florida | 32806 | — |
| Gold Coast Research, LLC | Plantation | Florida | 33317 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| National Pain Research Institute, LLC | Winter Park | Florida | 32789 | — |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | — |
| Drug Studies America | Marietta | Georgia | 30060 | — |
| Taylor Research, LLC | Marietta | Georgia | 30060 | — |
| In-Quest Medical Research, LLC | Norcross | Georgia | 30092 | — |
| Global Scientific Innovations | Evansville | Indiana | 47714 | — |
| Integrated Clinical Trials Services, Inc. | West Des Moines | Iowa | 50265 | — |
| Willis-Knighton Physician Network | Bossier City | Louisiana | 71111 | — |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | — |
| Best Clinical Trials, LLC | New Orleans | Louisiana | 70115 | — |
| River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | — |
| New England Center for Clinical Research, Inc. | Fall River | Massachusetts | 02720 | — |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | — |
| Cadillac Clinical Research | Cadillac | Michigan | 49601 | — |
| The Center for Clinical Trials | Biloxi | Mississippi | 39531 | — |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | — |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | — |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Plains Medical Clinic, LLC | Fargo | North Dakota | 58104 | — |
| Clinical Inquest Center, Ltd | Beavercreek | Ohio | 45432 | — |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Optimed Research, Ltd. | Tiffin | Ohio | 44883 | — |
| Brandywine Clinical Research | Downingtown | Pennsylvania | 19335 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Pain Specialists of Charleston, P.A. | Charleston | South Carolina | 29406 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| FutureSearch Clinical Trials | Austin | Texas | 78731 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | — |
| Advanced Clinical Research of Houston | Houston | Texas | 77062 | — |
| Innovative Clinical Trials | San Antonio | Texas | 78229 | — |
| Highland Clinical Research | Salt Lake City | Utah | 84124 | — |
| Clinical Investigations Specialist, Inc. | Kenosha | Wisconsin | 53142 | — |
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 NCT01755546, 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 Oct 17, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01755546 live on ClinicalTrials.gov.