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Efficacy and Safety Study of BEMA Buprenorphine in Subjects With Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
BioDelivery Sciences International
ClinicalTrials.gov Identifier:
NCT01256450
First received: December 7, 2010
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to determine whether BEMA Buprenorphine is effective and safe in the treatment of chronic low back pain (CLBP).


Condition Intervention Phase
Pain
Low Back Pain
 Drug: BEMA Buprenorphine
Drug: BEMA Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by BioDelivery Sciences International:

Primary Outcome Measures:
  • Mean change in pain intensity [ Time Frame: Baseline (randomization) to Week 12 ] [ Designated as safety issue: No ]
    The average of the daily pain scores for Baseline and Week 12


Estimated Enrollment: 300
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (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
Placebo Comparator: BEMA Placebo
placebo buccal soluble film
 Drug: BEMA Placebo
buccal soluble film; applied to the buccal mucosa twice daily
Other Name: placebo buccal soluble film

Detailed Description:

This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of BEMA Buprenorphine versus BEMA Placebo in treating chronic low back pain (CLBP) in subjects.

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 low back pain for ≥3 months with a pain intensity ≥5 [11 point numerical rating scale] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, NSAIDs, and muscle relaxants) of approximately 12 to 24 hours
  • Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
  • Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening 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 at Screening, prior to any procedure being performed

Exclusion Criteria:

  • Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
  • Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
  • History of severe emesis with opioids
  • Clinically significant sleep apnea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256450

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

No publications provided

Responsible Party: Andrew Finn, PharmD, Executive Vice President, Product Development, BioDelivery Sciences International, Inc.
ClinicalTrials.gov Identifier: NCT01256450     History of Changes
Other Study ID Numbers: BUP-301
Study First Received: December 7, 2010
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by BioDelivery Sciences International:
buccal soluble film
enriched enrollment
randomized withdrawal

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 23, 2013