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

Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01431742
• Other study ID #: BUP-306
• Status: Withdrawn
• Phase: Phase 3
• First received: September 8, 2011
• Last updated: April 16, 2012
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2012
• Source: BioDelivery Sciences International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pain

Intervention

Drug:
• BEMA Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioDelivery Sciences International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No