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

Sponsor

BioDelivery Sciences International (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01431742

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Low Back Pain	Drug: BEMA Buprenorphine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2013

Anticipated Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BEMA Buprenorphine buprenorphine buccal soluble film	Drug: BEMA Buprenorphine buccal soluble film; applied to the buccal mucosa twice daily Other Names: buprenorphine buccal soluble film

Arm

Intervention/Treatment

Experimental: BEMA Buprenorphine

buprenorphine buccal soluble film

Drug: BEMA Buprenorphine

buccal soluble film; applied to the buccal mucosa twice daily

Other Names:

buprenorphine buccal soluble film

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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