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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
Last Update Posted : January 13, 2017
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
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
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

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. Mean change in pain intensity [ Time Frame: Baseline up to approximately Week 52 ]
    The average of the visit pain scores for Baseline up to approximately Week 52

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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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Sponsors and Collaborators
BioDelivery Sciences International
Study Director: Andrew Finn, PharmD BioDelivery Sciences International

Responsible Party: BioDelivery Sciences International Identifier: NCT01298765     History of Changes
Other Study ID Numbers: BUP-305
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

Keywords provided by BioDelivery Sciences International:
buccal soluble film

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists