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Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01298765
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Information provided by (Responsible Party):
BioDelivery Sciences International

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

Condition or disease Intervention/treatment Phase
Pain Low Back Pain Osteoarthritis Neuropathic Pain Drug: BEMA Buprenorphine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: BEMA Buprenorphine
buprenorphine buccal soluble film
Drug: BEMA Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
Other Name: buprenorphine buccal soluble film

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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'.

  2. 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

  3. 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.

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01298765

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United States, Alabama
Birmingham, Alabama, United States
Mobile, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Arcadia, California, United States
Fresno, California, United States
La Jolla, California, United States
Long Beach, California, United States
United States, Colorado
Westminster, Colorado, United States
United States, Florida
DeLand, Florida, United States
Jupiter, Florida, United States
Plantation, Florida, United States
Port Orange, Florida, United States
United States, Georgia
Marietta, Georgia, United States
United States, Illinois
Bloomington, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
United States, Kansas
Leawood, Kansas, United States
United States, Massachusetts
Watertown, Massachusetts, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
New York, New York, United States
United States, North Carolina
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Altoona, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
El Paso, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Sponsors and Collaborators
BioDelivery Sciences International
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Study Director: Andrew Finn, PharmD BioDelivery Sciences International
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Responsible Party: BioDelivery Sciences International Identifier: NCT01298765    
Other Study ID Numbers: BUP-305
First Posted: February 18, 2011    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: March 2018
Keywords provided by BioDelivery Sciences International:
buccal soluble film
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists