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

This study has been completed.
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: December 7, 2010
Last updated: February 24, 2015
Last verified: February 2015

December 7, 2010
February 24, 2015
December 2010
July 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01256450 on ClinicalTrials.gov Archive Site
Not Provided
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Efficacy and Safety Study of BEMA Buprenorphine in Subjects With Low Back Pain
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
The purpose of this study is to determine whether BEMA Buprenorphine is effective and safe in the treatment of chronic low back pain (CLBP).

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.

Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Low Back Pain
  • Drug: BEMA Buprenorphine
    buccal soluble film; applied to the buccal mucosa twice daily
    Other Name: buprenorphine buccal soluble film
  • Drug: BEMA Placebo
    buccal soluble film; applied to the buccal mucosa twice daily
    Other Name: placebo buccal soluble film
  • Experimental: BEMA Buprenorphine
    buprenorphine buccal soluble film
    Intervention: Drug: BEMA Buprenorphine
  • Placebo Comparator: BEMA Placebo
    placebo buccal soluble film
    Intervention: Drug: BEMA Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2011
July 2011   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Endo Pharmaceuticals
Endo Pharmaceuticals
Not Provided
Study Director: Andrew Finn, PharmD BioDelivery Sciences International, Inc.
Endo Pharmaceuticals
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP