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WithdrawnNCT01431742Updated Apr 17, 2012

Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain

A Phase 3 interventional study of BEMA Buprenorphine in Pain and Low Back Pain, sponsored by BioDelivery Sciences International. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-17.

Sponsored by BioDelivery Sciences International · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
  • Low Back Pain

Keywords

  • buccal soluble film
  • Pain
  • Back Pain
  • Low Back Pain
  • Buprenorphine
  • Analgesics, Opioid
  • Analgesics
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In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

Browse Back Pain studies →

Lead sponsor

BioDelivery Sciences International is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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 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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    BEMA Buprenorphine

    buprenorphine buccal soluble film

    Drug: BEMA Buprenorphine

Interventions

  • DrugBEMA Buprenorphine

    buccal soluble film; applied to the buccal mucosa twice daily

    Also known as: buprenorphine buccal soluble film

06

What researchers measure

Primary outcomes

  1. Mean change in pain intensity

    The average of the visit pain scores for Baseline up to approximately Week 52

    Time frame: Baseline up to approximately Week 52

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Study locations

1 site
  • Marietta, Georgia, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01431742
Lead sponsor
BioDelivery Sciences International
Responsible party
Sponsor
First posted
Sep 12, 2011
Start date
Jul 2012
Primary completion
Jul 2013 (estimated)
Completion
Jul 2013 (estimated)
Last update
Apr 17, 2012

Study contacts

Andrew Finn, PharmD
study chair · BioDelivery Sciences International

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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