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

12 januari 2017 bijgewerkt door: BioDelivery Sciences International

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

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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

334

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35209
        • Alabama Orthopaedic Center - Research
      • Mobile, Alabama, Verenigde Staten, 36608
        • Coastal Clinical Research, Inc.
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85023
        • Arizona Research Center
    • California
      • Fresno, California, Verenigde Staten, 93710
        • Neuro-Pain Medical Center
      • La Jolla, California, Verenigde Staten, 92037
        • University of California, San Diego Medical Center, UCSD Center for Pain Medicine
      • Long Beach, California, Verenigde Staten, 90806
        • Collaborative Neuroscience Network, Inc.
    • Florida
      • DeLand, Florida, Verenigde Staten, 32720
        • Avail Clinical Research, LLC
      • Jupiter, Florida, Verenigde Staten, 33458
        • Health Awareness, Inc.
      • Plantation, Florida, Verenigde Staten, 33317
        • Gold Coast Research, LLC
      • Port Orange, Florida, Verenigde Staten, 32129
        • Accord Clinical Research, LLC
    • Georgia
      • Marietta, Georgia, Verenigde Staten, 30060
        • Taylor Research, LLC
    • Illinois
      • Bloomington, Illinois, Verenigde Staten, 61701
        • Millennium Pain Center
    • Indiana
      • Evansville, Indiana, Verenigde Staten, 47714
        • MediSphere Medical Research Center, LLC
    • Kansas
      • Leawood, Kansas, Verenigde Staten, 66211
        • International Clinical Research Institute
    • Massachusetts
      • Watertown, Massachusetts, Verenigde Staten, 02472
        • MedVadis Research Corporation
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89144
        • Office of Stephen H. Miller, MD
    • New York
      • New York, New York, Verenigde Staten, 10022
        • Research Across American
    • North Carolina
      • Raleigh, North Carolina, Verenigde Staten, 27612
        • Wake Research Associates, LLC
      • Winston-Salem, North Carolina, Verenigde Staten, 27103
        • The Center for Clinical Research, LLC
    • Pennsylvania
      • Altoona, Pennsylvania, Verenigde Staten, 16602
        • Allegheny Pain Management
    • Texas
      • Austin, Texas, Verenigde Staten, 78731
        • FutureSearch Trials of Neurology
      • El Paso, Texas, Verenigde Staten, 79902
        • Southwest Urgent Care Center
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84106
        • Lifetree Clinical Research
      • West Jordan, Utah, Verenigde Staten, 84088
        • Advanced Clinical Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: BEMA Buprenorfine
buprenorfine buccale oplosbare film
Geneesmiddel: Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
Andere namen:
  • BEMA Buprenorfine
  • BELBUCA
  • buprenorfine buccale oplosbare film
  • buprenorphine HCl buccal film
Placebo-vergelijker: BEMA Placebo
placebo buccal soluble film
Geneesmiddel: Placebo
buccal soluble film; applied to the buccal mucosa twice daily
Andere namen:
  • Placebo buccale film
  • BEMA-placebo
  • Placebo buccal soluble film

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Pain Intensity From Baseline to Week 12
Tijdsspanne: 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).
Baseline, Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Wijziging van baseline naar week 12 in Roland Morris Disability Questionnaire
Tijdsspanne: Basislijn, week 12
Proefpersonen beoordelen de handicap als gevolg van rugpijn met behulp van de Roland Morris Disability Questionnaire (RMDQ), bestaande uit 24 verklaringen van handicap. De score van de RMDQ is het totale aantal gecontroleerde items, variërend van 0 tot 24, waarbij hogere scores duiden op een grotere handicap.
Basislijn, week 12
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Tijdsspanne: 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).
Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
Number of Participants With Response to Treatment as Assessed by an NRS Scale
Tijdsspanne: 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).
Week 12
Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Tijdsspanne: 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.
Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Tijdsspanne: 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).
Baseline, Week 12
Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Tijdsspanne: 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).
Baseline, Week 12
Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
Tijdsspanne: 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).
Baseline, Week 12
Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
Tijdsspanne: 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).
Baseline, Week 12
Use of Rescue Medication
Tijdsspanne: 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.
Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

BioDelivery Sciences International

Onderzoekers

  • Studie directeur: Andrew Finn, PharmD, BioDelivery Sciences International, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2010

Primaire voltooiing (Werkelijk)

1 juli 2011

Studie voltooiing (Werkelijk)

1 juli 2011

Studieregistratiedata

Eerst ingediend

7 december 2010

Eerst ingediend dat voldeed aan de QC-criteria

7 december 2010

Eerst geplaatst (Schatting)

8 december 2010

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 februari 2017

Laatste update ingediend die voldeed aan QC-criteria

12 januari 2017

Laatst geverifieerd

1 januari 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BUP-301

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