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Completed

NCT Number: NCT01256450

Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).

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Key information

Conditions

Pain Back Pain Low Back Pain Neurologic Manifestations 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

Alabama Orthopaedic Center - Research, Birmingham, Alabama, United States

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About this study

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 buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.

Buprenorphine HCl buccal film 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.

Who can participate

Healthy volunteers accepted: No

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

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, nonsteroidal anti-inflammatory drugs [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
  • Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
  • Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram (ECG)
  • History of long QT syndrome, or an immediate family member with this condition
  • Diagnosis of moderate to severe hepatic impairment.
  • History of severe emesis with opioids
  • Clinically significant sleep apnea

Treatment and study plan

buprenorphine

Drug

buccal soluble film; applied to the buccal mucosa twice daily

Other names: buprenorphine buccal soluble film, BEMA Buprenorphine, BELBUCA, buprenorphine HCl buccal film

Placebo

Drug

buccal soluble film; applied to the buccal mucosa twice daily

Other names: Placebo buccal soluble film, Placebo buccal film, BEMA placebo

Primary outcomes

  1. Change in Pain Intensity From Baseline to Week 12

    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. Change From Baseline in Pain Intensity Over Time Using NRS Scale

    Time frame: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84

    Change in pain intensity = average of daily pain scores from the last 7 days prior to each 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).

  2. Number of Participants With Response to Treatment as Assessed by an NRS Scale

    Time frame: Week 12

    Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).

  3. 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 due to adverse event in the double-blind treatment phase.

  4. Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale

    Time frame: Baseline, Week 12

    Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).

  5. Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM

    Time frame: Baseline, Week 12

    The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).

  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 Subject's Overall Satisfaction With Study Drug

    Time frame: Baseline, Week 12

    Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).

  8. Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug

    Time frame: Baseline, Week 12

    Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).

  9. Use of Rescue Medication

    Time frame: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase

    Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.

Sponsors and collaborators

Lead sponsor

BioDelivery Sciences International

Industry

Registry information

Official study title

A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 8, 2010
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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