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Completed Phase 3 Interventional Results available

Long-term Open-Label Safety Study to Evaluate EN3409

ClinicalTrials.gov ID: NCT01755546

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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:23 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 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

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
Dec 2012 (Type not available)
Primary completion
Oct 2014 (Actual)
Completion
Nov 2014 (Actual)
Last update posted
Oct 18, 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 18, 2018 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01755546 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →