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

NCT01431742 | Withdrawn Phase 3

• 1 other identifier: BUP-306
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Low Back Pain

Keywords

buccal soluble film; Pain; Back Pain; Low Back Pain; Buprenorphine; Analgesics, Opioid; Analgesics

Outcome Measures

Primary Outcomes (1)

• Mean change in pain intensity

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

  Baseline up to approximately Week 52

Study Arms (1)

BEMA Buprenorphine

EXPERIMENTAL

buprenorphine buccal soluble film

Drug: BEMA Buprenorphine

Interventions

BEMA Buprenorphine DRUG

buccal soluble film; applied to the buccal mucosa twice daily

Also known as: buprenorphine buccal soluble film

BEMA Buprenorphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioDelivery Sciences International: lead

Study Sites (1)

Unknown Facility

Marietta, Georgia, United States

Location

MeSH Terms

Conditions

Pain; Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Finn, PharmD

  BioDelivery Sciences International

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 12, 2011
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 17, 2012

Record last verified: 2012-04

Locations

US (1)