Back to resultsLongterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain
Primary Purpose
Pain, Low Back Pain
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BEMA Buprenorphine
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring buccal soluble film, Pain, Back Pain, Low Back Pain, Buprenorphine, Analgesics, Opioid, Analgesics
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported during screening following discontinuation of current pain medication (opioids and NSAIDs) AND currently taking ≥10 mg oral morphine equivalent/day for ≥2 weeks
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BEMA Buprenorphine
Arm Description
buprenorphine buccal soluble film
Outcomes
Primary Outcome Measures
Mean change in pain intensity
The average of the visit pain scores for Baseline up to approximately Week 52
Secondary Outcome Measures
Full Information
NCT ID
NCT01431742
First Posted
September 8, 2011
Last Updated
April 16, 2012
Sponsor
BioDelivery Sciences International
1. Study Identification
Unique Protocol Identification Number
NCT01431742
Brief Title
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain
Official Title
An Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioDelivery Sciences International
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain.
BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Low Back Pain
Keywords
buccal soluble film, Pain, Back Pain, Low Back Pain, Buprenorphine, Analgesics, Opioid, Analgesics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BEMA Buprenorphine
Arm Type
Experimental
Arm Description
buprenorphine buccal soluble film
Intervention Type
Drug
Intervention Name(s)
BEMA Buprenorphine
Other Intervention Name(s)
buprenorphine buccal soluble film
Intervention Description
buccal soluble film; applied to the buccal mucosa twice daily
Primary Outcome Measure Information:
Title
Mean change in pain intensity
Description
The average of the visit pain scores for Baseline up to approximately Week 52
Time Frame
Baseline up to approximately Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant and non-nursing female aged 18 or older
History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported during screening following discontinuation of current pain medication (opioids and NSAIDs) AND currently taking ≥10 mg oral morphine equivalent/day for ≥2 weeks
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Finn, PharmD
Organizational Affiliation
BioDelivery Sciences International
Official's Role
Study Chair
Facility Information:
City
Marietta
State/Province
Georgia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain
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