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Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International
ClinicalTrials.gov Identifier:
NCT01298765
First received: February 16, 2011
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Pain
Low Back Pain
Osteoarthritis
Neuropathic Pain
 Drug: BEMA Buprenorphine
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BioDelivery Sciences International:

Primary Outcome Measures:
  • Mean change in pain intensity [ Time Frame: Baseline up to approximately Week 52 ] [ Designated as safety issue: No ]
    The average of the visit pain scores for Baseline up to approximately Week 52


Estimated Enrollment: 300
Study Start Date: March 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BEMA Buprenorphine
buprenorphine buccal soluble film
 Drug: BEMA Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
Other Name: buprenorphine buccal soluble film

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298765

  Show 26 Study Locations
Sponsors and Collaborators
BioDelivery Sciences International
Investigators
Study Director: Andrew Finn, PharmD BioDelivery Sciences International
  More Information

No publications provided

Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT01298765     History of Changes
Other Study ID Numbers: BUP-305
Study First Received: February 16, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by BioDelivery Sciences International:
buccal soluble film

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neuralgia
Osteoarthritis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 21, 2013