Long-term Open-Label Safety Study to Evaluate EN3409
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
1 other identifier
interventional
304
1 country
57
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 low-back-pain
Started Dec 2012
Typical duration for phase_3 low-back-pain
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 19, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
September 12, 2018
CompletedOctober 18, 2018
March 1, 2018
1.8 years
December 19, 2012
March 16, 2018
September 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented.
48 weeks
Study Arms (1)
EN3409
EXPERIMENTALBuprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily
Interventions
Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily
Eligibility Criteria
You may qualify if:
- Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year
- Male subjects who are practicing abstinence, surgically sterile, or are using a medically acceptable form of contraception
- De Novo subject with a clinical diagnosis of moderate to severe noncancer-related CP (eg, CLBP, OA, neuropathic pain) for ≥ 3 months
- De Novo subject that is treating their CP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥ 60 mg and ≤ 160 mg Morphine Sulfate Equivalent (MSE) per day for ≥ 4 weeks
- Stable health, as determined by the Principal Investigator
- Subject is willing and able to comply with all protocol required visits and assessments
- Rollover subject who has completed the 12-week Double-blind Treatment Phase in the EN3409-307/308 clinical study
You may not qualify if:
- A history or current evidence of any clinically significant disorder or any other condition, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
- Females who are pregnant, breastfeeding, or plan to become pregnant during the study
- Current cancer-related pain or received chemotherapy within 6 months of screening
- Subjects receiving opioid analgesic medication \< 60 mg MSE per day within 28 days of screening
- De novo subjects receiving opioid analgesic medication at doses of \> 160 mg MSE per day within 28 days of screening
- Subjects with a history of other chronic painful conditions, other than the index CP condition, which require frequent analgesic medication
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- History of allergy or contraindications to any opioid or acetaminophen
- Surgical procedure for relief of pain within 6 months, or nerve/plexus block within 28 days of screening
- Hypokalemia or clinically unstable cardiac disease
- Moderate to severe hepatic impairment
- Moderate to severe renal impairment
- Current or past history of alcohol or substance
- Positive urine toxicology screen for drugs of abuse
- History of abnormalities on physical exam, vital signs, ECG, or lab values
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Horizon Research Group, Inc
Mobile, Alabama, 36608, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Global Research, LLC
Anaheim, California, 92804, United States
Synergy Clinical Research Center of Escondido
Escondido, California, 92025, United States
RX Clinical Research, Inc.
Garden Grove, California, 92843, United States
Long Beach Center for Clinical Research
Long Beach, California, 90807, United States
Adam D. Karns, MD
Los Angeles, California, 90036, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Century Clinical Research, Inc.
Daytona Beach, Florida, 32117, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Florida Health Center
Fort Lauderdale, Florida, 33312, United States
Eastern Research, Inc.
Hialeah, Florida, 33013, United States
Southeast Clinical Research, LLC
Jacksonville, Florida, 32216, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Research Centers of America, LLC
Oakland Park, Florida, 33334, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Ribo Research LLC DBA Peninsula Research
Ormond Beach, Florida, 32806, United States
Gold Coast Research, LLC
Plantation, Florida, 33317, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
National Pain Research Institute, LLC
Winter Park, Florida, 32789, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Taylor Research, LLC
Marietta, Georgia, 30060, United States
In-Quest Medical Research, LLC
Norcross, Georgia, 30092, United States
Global Scientific Innovations
Evansville, Indiana, 47714, United States
Integrated Clinical Trials Services, Inc.
West Des Moines, Iowa, 50265, United States
Willis-Knighton Physician Network
Bossier City, Louisiana, 71111, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115, United States
River Cities Clinical Research Center
Shreveport, Louisiana, 71105, United States
New England Center for Clinical Research, Inc.
Fall River, Massachusetts, 02720, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Cadillac Clinical Research
Cadillac, Michigan, 49601, United States
The Center for Clinical Trials
Biloxi, Mississippi, 39531, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Plains Medical Clinic, LLC
Fargo, North Dakota, 58104, United States
Clinical Inquest Center, Ltd
Beavercreek, Ohio, 45432, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Optimed Research, Ltd.
Tiffin, Ohio, 44883, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Pain Specialists of Charleston, P.A.
Charleston, South Carolina, 29406, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
FutureSearch Clinical Trials
Austin, Texas, 78731, United States
KRK Medical Research
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
Advanced Clinical Research of Houston
Houston, Texas, 77062, United States
Innovative Clinical Trials
San Antonio, Texas, 78229, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
Clinical Investigations Specialist, Inc.
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Operations
- Organization
- BIODELIVERY
Study Officials
- STUDY DIRECTOR
Andrew Finn, PharmD
BioDelivary Sciences Internantional, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2012
First Posted
December 24, 2012
Study Start
December 1, 2012
Primary Completion
October 1, 2014
Study Completion
November 1, 2014
Last Updated
October 18, 2018
Results First Posted
September 12, 2018
Record last verified: 2018-03