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

12. januar 2017 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

334

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BEMA Buprenorphin
buprenorphin bukkal opløselig film
Medicin: Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
Andre navne:
  • BEMA Buprenorphin
  • BELBUCA
  • buprenorphin bukkal opløselig film
  • buprenorphine HCl buccal film
Placebo komparator: BEMA Placebo
placebo buccal soluble film
Medicin: Placebo
buccal soluble film; applied to the buccal mucosa twice daily
Andre navne:
  • Placebo bukal film
  • BEMA placebo
  • Placebo buccal soluble film

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Intensity From Baseline to Week 12
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skift fra baseline til uge 12 i Roland Morris handicapspørgeskema
Tidsramme: Baseline, uge ​​12
Forsøgspersoner vurderer handicap på grund af rygsmerter ved hjælp af Roland Morris Disability Questionnaire (RMDQ) bestående af 24 erklæringer om handicap. Score for RMDQ er det samlede antal kontrollerede elementer, der spænder fra 0 til 24 med højere score, der indikerer større handicap.
Baseline, uge ​​12
Change From Baseline in Pain Intensity Over Time Using NRS Scale
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BioDelivery Sciences International

Efterforskere

  • Studieleder: Andrew Finn, PharmD, BioDelivery Sciences International, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2010

Primær færdiggørelse (Faktiske)

1. juli 2011

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

7. december 2010

Først indsendt, der opfyldte QC-kriterier

7. december 2010

Først opslået (Skøn)

8. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BUP-301

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smerte

Kliniske forsøg med Buprenorphine

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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