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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01256450
First received: December 7, 2010
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
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).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Change in Pain Intensity From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Response to Treatment as Assessed by an NRS Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.

  • Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline to Week 12 in Roland Morris Disability Questionnaire [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 Subject's Overall Satisfaction With Study Drug [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).

  • Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).

  • Use of Rescue Medication [ Time Frame: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase ] [ Designated as safety issue: No ]
    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.


Enrollment: 334
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BEMA Buprenorphine
buprenorphine buccal soluble film
Drug: Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
Other Names:
  • buprenorphine buccal soluble film
  • BEMA Buprenorphine
  • BELBUCA
  • buprenorphine HCl buccal film
Placebo Comparator: BEMA Placebo
placebo buccal soluble film
Drug: Placebo
buccal soluble film; applied to the buccal mucosa twice daily
Other Names:
  • Placebo buccal soluble film
  • Placebo buccal film
  • BEMA placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT01256450

  Show 24 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Andrew Finn, PharmD BioDelivery Sciences International, Inc.
  More Information

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01256450     History of Changes
Other Study ID Numbers: BUP-301 
Study First Received: December 7, 2010
Results First Received: November 4, 2015
Last Updated: August 1, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
buccal soluble film
enriched enrollment
randomized withdrawal

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
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

ClinicalTrials.gov processed this record on September 23, 2016