Long-term Open-Label Safety Study to Evaluate EN3409

September 20, 2018 updated by: BioDelivery Sciences International

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
304

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
Time Frame: 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.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioDelivery Sciences International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andrew Finn, PharmD, BioDelivary Sciences Internantional, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EN3409-309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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