Long-term Open-Label Safety Study to Evaluate EN3409
- Registration Number
- NCT01755546
- Lead Sponsor
- BioDelivery Sciences International
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EN3409 EN3409 Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score 48 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (56)
Horizon Research Group, Inc
🇺🇸Mobile, Alabama, United States
Taylor Research, LLC
🇺🇸Marietta, Georgia, United States
Long Island Gastrointestinal Research Group
🇺🇸Great Neck, New York, United States
KRK Medical Research
🇺🇸Dallas, Texas, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
Long Beach Center for Clinical Research
🇺🇸Long Beach, California, United States
Global Research, LLC
🇺🇸Anaheim, California, United States
RX Clinical Research, Inc.
🇺🇸Garden Grove, California, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
Synergy Clinical Research Center of Escondido
🇺🇸Escondido, California, United States
Adam D. Karns, MD
🇺🇸Los Angeles, California, United States
Century Clinical Research, Inc.
🇺🇸Daytona Beach, Florida, United States
Eastern Research, Inc.
🇺🇸Hialeah, Florida, United States
Florida Health Center
🇺🇸Fort Lauderdale, Florida, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Southeast Clinical Research, LLC
🇺🇸Jacksonville, Florida, United States
Ribo Research LLC DBA Peninsula Research
🇺🇸Ormond Beach, Florida, United States
Gold Coast Research, LLC
🇺🇸Plantation, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
National Pain Research Institute, LLC
🇺🇸Winter Park, Florida, United States
River Birch Research Alliance, LLC
🇺🇸Blue Ridge, Georgia, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
In-Quest Medical Research, LLC
🇺🇸Norcross, Georgia, United States
Integrated Clinical Trials Services, Inc.
🇺🇸West Des Moines, Iowa, United States
Global Scientific Innovations
🇺🇸Evansville, Indiana, United States
Willis-Knighton Physician Network
🇺🇸Bossier City, Louisiana, United States
New England Center for Clinical Research, Inc.
🇺🇸Fall River, Massachusetts, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
The Center for Clinical Trials
🇺🇸Biloxi, Mississippi, United States
Cadillac Clinical Research
🇺🇸Cadillac, Michigan, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
Plains Medical Clinic, LLC
🇺🇸Fargo, North Dakota, United States
Clinical Inquest Center, Ltd
🇺🇸Beavercreek, Ohio, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Optimed Research, Ltd.
🇺🇸Tiffin, Ohio, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Advanced Clinical Research of Houston
🇺🇸Houston, Texas, United States
Clinical Investigations Specialist, Inc.
🇺🇸Kenosha, Wisconsin, United States
River Cities Clinical Research Center
🇺🇸Shreveport, Louisiana, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Research Centers of America, LLC
🇺🇸Oakland Park, Florida, United States
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
Brandywine Clinical Research
🇺🇸Downingtown, Pennsylvania, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
FutureSearch Clinical Trials
🇺🇸Austin, Texas, United States
Best Clinical Trials, LLC
🇺🇸New Orleans, Louisiana, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Pain Specialists of Charleston, P.A.
🇺🇸Charleston, South Carolina, United States