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Completed

NCT Number: NCT01633944

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

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.

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Key information

Conditions

Low Back Pain Back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Horizon Research Group, Inc./Alabama Orthopedic Clinic, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily

Other names: BELBUCA, Buprenorphine HCl Buccal Film, BEMA Buprenorphine, EN3409

Placebo

Drug

Matching Placebo Buccal Film twice daily

Other names: Placebo Buccal Film, BEMA Placebo

Primary outcomes

  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 outcomes

  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 NRS ranging from 0 (no pain) to 10 (worst pain imaginable).

  2. 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.

  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 "optimal" 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 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).

Sponsors and collaborators

Lead sponsor

BioDelivery Sciences International

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 6, 2012
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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