Clinical trial NCT01755546: Long-term Open-Label Safety Study to Evaluate EN3409
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Osteoarthritis
Neuropathic Pain
Keywords: Chronic Pain
CLBP
Chronic Low Back Pain
Back Pain
Osteoarthritis
OA
Neuropathic Pain
Nerve pain
Painful neuropathy
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
First posted: 2012-12-24
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group, Inc
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Global Research, LLC
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research Center of Escondido
state: California
city: Garden Grove
country: United States
facility: RX Clinical Research, Inc.
state: California
city: Long Beach
country: United States
facility: Long Beach Center for Clinical Research
state: California
city: Los Angeles
country: United States
facility: Adam D. Karns, MD
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Daytona Beach
country: United States
facility: Century Clinical Research, Inc.
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Health Center
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Southeast Clinical Research, LLC
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Oakland Park
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Ribo Research LLC DBA Peninsula Research
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Winter Park
country: United States
facility: National Pain Research Institute, LLC
state: Florida
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Marietta
country: United States
facility: Taylor Research, LLC
state: Georgia
city: Norcross
country: United States
facility: In-Quest Medical Research, LLC
state: Georgia
city: Evansville
country: United States
facility: Global Scientific Innovations
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trials Services, Inc.
state: Iowa
city: Bossier City
country: United States
facility: Willis-Knighton Physician Network
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC
state: Louisiana
city: Shreveport
country: United States
facility: River Cities Clinical Research Center
state: Louisiana
city: Fall River
country: United States
facility: New England Center for Clinical Research, Inc.
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Cadillac
country: United States
facility: Cadillac Clinical Research
state: Michigan
city: Biloxi
country: United States
facility: The Center for Clinical Trials
state: Mississippi
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Fargo
country: United States
facility: Plains Medical Clinic, LLC
state: North Dakota
city: Beavercreek
country: United States
facility: Clinical Inquest Center, Ltd
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Tiffin
country: United States
facility: Optimed Research, Ltd.
state: Ohio
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Pain Specialists of Charleston, P.A.
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Austin
country: United States
facility: FutureSearch Clinical Trials
state: Texas
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Houston
country: United States
facility: Advanced Clinical Research of Houston
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Kenosha
country: United States
facility: Clinical Investigations Specialist, Inc.
state: Wisconsin
Study officials:
affiliation: BioDelivary Sciences Internantional, Inc.
name: Andrew Finn, PharmD
role: STUDY_DIRECTOR
References: