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

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 Overview

• Status: Completed
• Conditions: Osteoarthritis; Low Back Pain; Neuropathic Pain
• Intervention / Treatment: Drug: EN3409

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35215
      • Parkway Medical Center
    • Mobile, Alabama, United States, 36608
      • Horizon Research Group, Inc
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
  • California
    • Anaheim, California, United States, 92804
      • Global Research, LLC
    • Escondido, California, United States, 92025
      • Synergy Clinical Research Center Of Escondido
    • Garden Grove, California, United States, 92843
      • RX Clinical Research, Inc.
    • Long Beach, California, United States, 90807
      • Long Beach Center For Clinical Research
    • Los Angeles, California, United States, 90036
      • Adam D. Karns, MD
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • Daytona Beach, Florida, United States, 32117
      • Century Clinical Research, Inc.
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Fort Lauderdale, Florida, United States, 33312
      • Florida Health Center
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc.
    • Jacksonville, Florida, United States, 32216
      • Southeast Clinical Research, LLC
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Oakland Park, Florida, United States, 33334
      • Research Centers of America, LLC
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Ormond Beach, Florida, United States, 32806
      • Ribo Research LLC DBA Peninsula Research
    • Plantation, Florida, United States, 33317
      • Gold Coast Research, LLC
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
    • Winter Park, Florida, United States, 32789
      • National Pain Research Institute, LLC
  • Georgia
    • Blue Ridge, Georgia, United States, 30513
      • River Birch Research Alliance, Llc
    • Marietta, Georgia, United States, 30060
      • Taylor Research, LLC
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
    • Norcross, Georgia, United States, 30092
      • In-Quest Medical Research, LLC
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Global Scientific Innovations
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trials Services, Inc.
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Willis-Knighton Physician Network
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management, LLC
    • New Orleans, Louisiana, United States, 70115
      • Best Clinical Trials, LLC
    • Shreveport, Louisiana, United States, 71105
      • River Cities Clinical Research Center
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research, Inc.
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Cadillac, Michigan, United States, 49601
      • Cadillac Clinical Research
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • The Center for Clinical Trials
  • New York
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Medical Clinic, LLC
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Clinical Inquest Center, Ltd
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
    • Tiffin, Ohio, United States, 44883
      • Optimed Research, Ltd.
  • Pennsylvania
    • Downingtown, Pennsylvania, United States, 19335
      • Brandywine Clinical Research
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Pain Specialists of Charleston, P.A.
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Clinical Trials
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • Dallas, Texas, United States, 75230
      • KRK Medical Research
    • Houston, Texas, United States, 77062
      • Advanced Clinical Research of Houston
    • San Antonio, Texas, United States, 78229
      • Innovative Clinical Trials
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Clinical Investigations Specialist, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EN3409; Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily	Drug: EN3409; Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily; Other Names: Buprenorphine HCI Buccal Film 300-900 mcg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: BioDelivery Sciences International
• Investigators: Study Director: Andrew Finn, PharmD, BioDelivary Sciences Internantional, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (ESTIMATE): December 24, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Osteoarthritis; Chronic Pain; Chronic Low Back Pain; Back Pain; CLBP; Neuropathic Pain; OA; Nerve pain; Painful neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Neuromuscular Diseases; Peripheral Nervous System Diseases; Osteoarthritis; Back Pain; Low Back Pain; Neuralgia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: EN3409-309