Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

August 5, 2018 updated by: BioDelivery Sciences International

A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain

The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • 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
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Arcadia, California, United States
      • Fresno, California, United States
      • La Jolla, California, United States
      • Long Beach, California, United States
    • Colorado
      • Westminster, Colorado, United States
    • Florida
      • DeLand, Florida, United States
      • Jupiter, Florida, United States
      • Plantation, Florida, United States
      • Port Orange, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Bloomington, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
    • Kansas
      • Leawood, Kansas, United States
    • Massachusetts
      • Watertown, Massachusetts, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
      • El Paso, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
      • West Jordan, Utah, United States

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BEMA Buprenorphine
buprenorphine buccal soluble film
Drug: BEMA Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
Other Names:
  • buprenorphine buccal soluble film

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in NRS Pain Intensity
Time Frame: Baseline up to approximately Week 52
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change in Pain Intensity
Time Frame: Baseline to Week 28
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'.
Baseline to Week 28
Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
Time Frame: Baseline to Week 28
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
Baseline to Week 28
Subjects Overall Satisfaction With Study Drug
Time Frame: Baseline to Week 52
Subjects Overall Satisfaction with Study Drug as measured on a 5 point scale, with 1 being not satisfied and 5 being very satisified.
Baseline to Week 52
Investigator's Overall Satisfaction With Study Drug
Time Frame: Baseline to Week 52
Investigator's Overall Satisfaction with Study Drug measured on a 5-point scale, with 1 being not satisfied and 5 being very satisfied.
Baseline to Week 52

Collaborators and Investigators

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

Sponsor

BioDelivery Sciences International

Investigators

  • Study Director: Andrew Finn, PharmD, BioDelivery Sciences International

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

March 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUP-305

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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