Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain
1 other identifier
interventional
302
1 country
26
Brief Summary
The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pain
Started Mar 2011
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
February 18, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
August 7, 2018
CompletedAugust 7, 2018
March 1, 2018
1.4 years
February 16, 2011
March 16, 2018
August 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in NRS Pain Intensity
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 used to calculate the change from baseline at week 52.
Baseline up to approximately Week 52
Secondary Outcomes (4)
Patient Global Impression of Change in Pain Intensity
Baseline to Week 28
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
Baseline to Week 28
Subjects Overall Satisfaction With Study Drug
Baseline to Week 52
Investigator's Overall Satisfaction With Study Drug
Baseline to Week 52
Study Arms (1)
BEMA Buprenorphine
EXPERIMENTALbuprenorphine buccal soluble film
Interventions
buccal soluble film; applied to the buccal mucosa twice daily
Eligibility Criteria
You may qualify if:
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic pain:
- Subjects completing study BUP-301 (low back pain) or
- Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 months with a pain intensity ≥5 \[11 point NRS\] reported at the titration period Day 0/1 visit following a washout period (opioids, NSAIDs, and muscle relaxants) of approximately 12 to 24 hours AND currently taking ≤60 mg oral morphine equivalent/day (including opioid-naïve) for 1 week or longer
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and laboratory results so as to comply with all study procedures
- Female subjects of childbearing potential must be using a recognized effective method of birth control
- Written informed consent obtained prior to any procedure being performed
You may not qualify if:
- Cancer related pain
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit
- History of severe emesis with opioids
- Clinically significant sleep apnea in the judgment of the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Arcadia, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Westminster, Colorado, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
Plantation, Florida, United States
Unknown Facility
Port Orange, Florida, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Bloomington, Illinois, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Leawood, Kansas, United States
Unknown Facility
Watertown, Massachusetts, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Altoona, Pennsylvania, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
El Paso, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
West Jordan, Utah, 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
BioDelivery Sciences International
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
February 16, 2011
First Posted
February 18, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
August 7, 2018
Results First Posted
August 7, 2018
Record last verified: 2018-03