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Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects

This study has been completed.
Information provided by (Responsible Party):
BioDelivery Sciences International Identifier:
First received: July 2, 2012
Last updated: January 12, 2017
Last verified: January 2017
The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

Resource links provided by NLM:

Further study details as provided by BioDelivery Sciences International:

Primary Outcome Measures:
  • Change From Baseline to Week 12 in Average Daily Pain Intensity Scores [ Time Frame: Baseline, Week 12 ]
    Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

Secondary Outcome Measures:
  • Number of Participants With Response to Treatment (Responder) Using NRS Scale [ Time Frame: Prior to open-label titration to Week 12 in double-blind treatment ]
    Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable).

  • Number of Subjects With Rescue Medication Use [ Time Frame: Week 1 to Week 12 in double-blind treatment ]
    Use of analgesic rescue medication recorded in subject diary.

  • Time to Optimal Dose of Open-label Study Medication [ Time Frame: Up to 8 weeks in open-label titration ]
    Overall time to reach the "optimal" dose of study medication required to progress to double-blind treatment.

  • Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) [ Time Frame: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks) ]
    Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.

  • Patient Global Impression of Change [ Time Frame: Week 12 ]
    Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)

  • Change From Baseline to Week 12 in Roland Morris Disability Questionnaire [ Time Frame: Baseline, Week 12 ]
    Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.

  • Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale [ Time Frame: Baseline, Week 12 ]
    Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).

Enrollment: 752
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Twice Daily Dosing
Drug: Placebo
Matching Placebo Buccal Film twice daily
Other Names:
  • Placebo Buccal Film
  • BEMA Placebo
Experimental: Buprenorphine HCl Buccal Film
Twice Daily Dosing
Drug: Buprenorphine
Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily
Other Names:
  • Buprenorphine HCl Buccal Film
  • BEMA Buprenorphine
  • EN3409


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of moderate to severe low back pain for ≥6 months
  • Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed [PRN] non-opioid analgesic medications permitted on top of the stable daily maintenance dose of non-opioid analgesic)
  • Stable health, as determined by Principal Investigator
  • Are female who are practicing abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year
  • Willing and able to comply with all protocol required visits and assessments

Exclusion Criteria:

  • Current cancer related pain or received chemotherapy with 6 months of screening
  • Receiving opioid analgesic medication >10 mg MSE per day within 28 days of screening
  • Subjects with a history of other chronic painful conditions
  • Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
  • Allergy or contraindications to any opioid or acetaminophen
  • Surgical procedure for relief of pain with 6 months
  • Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
  • QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
  • History of long QT syndrome or a family member with this condition
  • Moderate to severe hepatic impairment
  • Moderate to severe renal impairment
  • Current or past history of alcohol abuse
  • Positive urine toxicology screen for drug of abuse
  • History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01633944

  Show 60 Study Locations
Sponsors and Collaborators
BioDelivery Sciences International
Study Director: M. Todd Kirby, PhD Endo Pharmaceuticals
  More Information

Responsible Party: BioDelivery Sciences International Identifier: NCT01633944     History of Changes
Other Study ID Numbers: EN3409-308
Study First Received: July 2, 2012
Results First Received: November 3, 2015
Last Updated: January 12, 2017

Keywords provided by BioDelivery Sciences International:
Chronic Low Back Pain
Chronic Pain
Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on April 28, 2017