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

Phase 3

Withdrawn

• Conditions: Pain; Low Back Pain
• Interventions: Drug: BEMA Buprenorphine

• Registration Number: NCT01431742
• Lead Sponsor: BioDelivery Sciences International

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-17
• Study Start: 2012-07
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BEMA Buprenorphine	BEMA Buprenorphine	buprenorphine buccal soluble film

Primary Outcome Measures

Name	Time	Method
Mean change in pain intensity	Baseline up to approximately Week 52	The average of the visit pain scores for Baseline up to approximately Week 52