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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International
ClinicalTrials.gov Identifier:
NCT01431742
First received: September 8, 2011
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Pain
Low Back Pain
Drug: BEMA Buprenorphine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by BioDelivery Sciences International:

Primary Outcome Measures:
  • Mean change in pain intensity [ Time Frame: Baseline up to approximately Week 52 ] [ Designated as safety issue: No ]
    The average of the visit pain scores for Baseline up to approximately Week 52


Enrollment: 0
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431742

Locations
United States, Georgia
Marietta, Georgia, United States
Sponsors and Collaborators
BioDelivery Sciences International
Investigators
Study Chair: Andrew Finn, PharmD BioDelivery Sciences International
  More Information

No publications provided

Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT01431742     History of Changes
Other Study ID Numbers: BUP-306
Study First Received: September 8, 2011
Last Updated: April 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BioDelivery Sciences International:
buccal soluble film
Pain
Back Pain
Low Back Pain
Buprenorphine
Analgesics, Opioid
Analgesics

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 30, 2014