search
Back to results

Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

Primary Purpose

Pain, Low Back Pain, Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BEMA Buprenorphine
Sponsored by
BioDelivery Sciences International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring buccal soluble film

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or non-pregnant and non-nursing female aged 18 or older

  • History of moderate to severe chronic pain:

    1. Subjects completing study BUP-301 (low back pain) or
    2. 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

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

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.

Secondary Outcome Measures

Patient Global Impression of Change in Pain Intensity
Patient Global Impression of Change in Pain Intensity at Week 28 as measured by a 7 point scale. Patients measure their improvement from 7='very much improved', 6='much improved', 5='minimally improved', 4='no change', 3='minimally worse', 2='much worse', 1='very much worse'.
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction at Week 28. Patients complete a 14 item questionaire that measures 4 scales based on side effects, effectiveness, convenience and global satisfaction. All items have either five or seven responses (except item 4), scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales have a non-neutral midpoint, such that there are more positive response options than negative response options. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items
Subjects Overall Satisfaction With Study Drug
Subjects Overall Satisfaction with Study Drug as measured on a 5 point scale, with 1 being not satisfied and 5 being very satisified.
Investigator's Overall Satisfaction With Study Drug
Investigator's Overall Satisfaction with Study Drug measured on a 5-point scale, with 1 being not satisfied and 5 being very satisfied.

Full Information

First Posted
February 16, 2011
Last Updated
August 5, 2018
Sponsor
BioDelivery Sciences International
search

1. Study Identification

Unique Protocol Identification Number
NCT01298765
Brief Title
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
Official Title
A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

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
The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.
Detailed Description
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 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, Osteoarthritis, Neuropathic Pain
Keywords
buccal soluble film

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
302 (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
Change From Baseline in NRS Pain Intensity
Description
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.
Time Frame
Baseline up to approximately Week 52
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change in Pain Intensity
Description
Patient Global Impression of Change in Pain Intensity at Week 28 as measured by a 7 point scale. Patients measure their improvement from 7='very much improved', 6='much improved', 5='minimally improved', 4='no change', 3='minimally worse', 2='much worse', 1='very much worse'.
Time Frame
Baseline to Week 28
Title
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
Description
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction at Week 28. Patients complete a 14 item questionaire that measures 4 scales based on side effects, effectiveness, convenience and global satisfaction. All items have either five or seven responses (except item 4), scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales have a non-neutral midpoint, such that there are more positive response options than negative response options. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items
Time Frame
Baseline to Week 28
Title
Subjects Overall Satisfaction With Study Drug
Description
Subjects Overall Satisfaction with Study Drug as measured on a 5 point scale, with 1 being not satisfied and 5 being very satisified.
Time Frame
Baseline to Week 52
Title
Investigator's Overall Satisfaction With Study Drug
Description
Investigator's Overall Satisfaction with Study Drug measured on a 5-point scale, with 1 being not satisfied and 5 being very satisfied.
Time Frame
Baseline to 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 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 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 Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Mobile
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Arcadia
State/Province
California
Country
United States
City
Fresno
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Westminster
State/Province
Colorado
Country
United States
City
DeLand
State/Province
Florida
Country
United States
City
Jupiter
State/Province
Florida
Country
United States
City
Plantation
State/Province
Florida
Country
United States
City
Port Orange
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Bloomington
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Leawood
State/Province
Kansas
Country
United States
City
Watertown
State/Province
Massachusetts
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
New York
State/Province
New York
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Altoona
State/Province
Pennsylvania
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
El Paso
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
West Jordan
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

We'll reach out to this number within 24 hrs