Clinical trial NCT01298765: Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
Official title: A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Low Back Pain
Osteoarthritis
Neuropathic Pain
Keywords: buccal soluble film
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

Detailed description: 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 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.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant and non-nursing female aged 18 or older
* History of moderate to severe chronic pain:

  1. Subjects completing study BUP-301 (low back pain) or
  2. Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 months with a pain intensity ≥5 \[11 point NRS\] reported at the titration period Day 0/1 visit following a washout period (opioids, NSAIDs, and muscle relaxants) of approximately 12 to 24 hours AND currently taking ≤60 mg oral morphine equivalent/day (including opioid-naïve) for 1 week or longer
* 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

Primary outcomes:
measure: Change From Baseline in NRS Pain Intensity
timeFrame: Baseline up to approximately Week 52
Secondary outcomes:
measure: Patient Global Impression of Change in Pain Intensity
timeFrame: Baseline to Week 28
measure: Treatment Satisfaction Questionnaire for Medication/Global Satisfaction
timeFrame: Baseline to Week 28
measure: Subjects Overall Satisfaction With Study Drug
timeFrame: Baseline to Week 52
measure: Investigator's Overall Satisfaction With Study Drug
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Arcadia
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Westminster
country: United States
state: Colorado
city: DeLand
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Bloomington
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Leawood
country: United States
state: Kansas
city: Watertown
country: United States
state: Massachusetts
city: Las Vegas
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Altoona
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
Study officials:
affiliation: BioDelivery Sciences International
name: Andrew Finn, PharmD
role: STUDY_DIRECTOR
References: