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

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ClinicalTrials.gov Identifier: NCT01675167
Recruitment Status : Completed
First Posted : August 29, 2012
Results First Posted : February 3, 2016
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International

Brief Summary:
The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced 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 or disease Intervention/treatment Phase
Low Back Pain Drug: Buprenorphine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 815 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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-Experienced Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia
Study Start Date : September 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Placebo Comparator: Placebo Buccal Film
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 150-900 mcg twice daily
Other Names:
  • BELBUCA
  • Buprenorphine HCl Buccal Film
  • BEMA Buprenorphine
  • EN3409




Primary Outcome Measures :
  1. 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 :
  1. 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 numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

  2. Number of Subjects With Opioid Rescue Medication Use [ Time Frame: Week 1 to Week 12 ]
    Use of analgesic rescue medication recorded in subject diary

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

  4. 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.

  5. 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)

  6. 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.

  7. Change From Baseline to Week 12 in Medical Outcome 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).

  8. Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep [ Time Frame: 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 quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of moderate to severe low back pain for ≥6 months
  • Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed [PRN] analgesic rescue medications permitted on top of the stable daily maintenance dose of ≥30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)
  • Stable health, as determine by Principal Investigator
  • Females are practicing abstinence, using a medically acceptable form of contraception, or 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 within 6 months of screening
  • Subjects with 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 of any opioid or acetaminophen
  • Surgical procedure for relief of pain within 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675167


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Sponsors and Collaborators
BioDelivery Sciences International
Investigators
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Study Director: Andrew Finn, PharmD BioDelivery Sciences International, Inc.

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Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT01675167     History of Changes
Other Study ID Numbers: EN3409-307
First Posted: August 29, 2012    Key Record Dates
Results First Posted: February 3, 2016
Last Update Posted: February 27, 2017
Last Verified: January 2017
Keywords provided by BioDelivery Sciences International:
CLBP
Chronic Low Back Pain
Chronic Pain
Back Pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists