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

12. januar 2017 opdateret af: BioDelivery Sciences International

Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

815

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, 35215
        • Parkway Medical Center
      • Haleyville, Alabama, Forenede Stater, 35565
        • Haleyville Clinical Research LLC
      • Mobile, Alabama, Forenede Stater, 36608
        • Horizon Research Group. Inc / Alabama Orthopedice
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85023
        • Arizona Research Center
    • California
      • Anaheim, California, Forenede Stater, 92804
        • Global Research
      • Chino, California, Forenede Stater, 91710
        • Catalina Research Institute, LLC
      • Escondido, California, Forenede Stater, 92025
        • Synergy Clinical Research Center Of Escondido
      • Garden Grove, California, Forenede Stater, 92843
        • RX Clinical Research, Inc.
      • Los Angeles, California, Forenede Stater, 90036
        • Adam D. Karns, MD
    • Connecticut
      • Stamford, Connecticut, Forenede Stater, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Daytona Beach, Florida, Forenede Stater, 32117
        • Century Clinic Research
      • Deland, Florida, Forenede Stater, 32720
        • Avail Clinical Research, LLC
      • Ft. Lauderdale, Florida, Forenede Stater, 33312
        • Florida Health Center
      • Hialeah, Florida, Forenede Stater, 33013
        • Eastern Research, Inc.
      • Jacksonville, Florida, Forenede Stater, 32257
        • Florida Institute of Medical Research
      • Jupiter, Florida, Forenede Stater, 33458
        • Health Awareness, Inc.
      • Jupiter, Florida, Forenede Stater, 33458
        • Drug Study Institute
      • Kissimmee, Florida, Forenede Stater, 34741
        • FPA Clinical Research
      • Maitland, Florida, Forenede Stater, 32751
        • Try Research, Inc.
      • Naples, Florida, Forenede Stater, 34108
        • NEMA Research, Inc.
      • Orlando, Florida, Forenede Stater, 32806
        • Compass Research, LLC
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Peninsula Research, Inc.
      • Plantation, Florida, Forenede Stater, 33317
        • Gold Coast Research, LLC
      • Port Orange, Florida, Forenede Stater, 32127
        • Progressive Medical Research
      • Tampa, Florida, Forenede Stater, 33603
        • Clinical Research of West Florida, Inc.
      • West Palm Beach, Florida, Forenede Stater, 33409
        • Palm Beach Research Center
      • Winter Park, Florida, Forenede Stater, 32789
        • National Pain Research Institute, LLC
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30319
        • Atlanta Research Center
      • Blue Ridge, Georgia, Forenede Stater, 30513
        • River Birch Research Alliance, LLC
      • Marietta, Georgia, Forenede Stater, 30060
        • Georgia Institute for Clinical Research, LLC
      • Marietta, Georgia, Forenede Stater, 30060
        • Taylor Research, LLC
      • Marietta, Georgia, Forenede Stater, 30060
        • Drug Studies America
      • Newnan, Georgia, Forenede Stater, 30265
        • Georgia Pain & Spine Care & Better Health Clinical Research
    • Illinois
      • Gurnee, Illinois, Forenede Stater, 60031
        • Clinical Investigations Specialists, Inc.
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47714
        • MediSphere Medical Research, LLC
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50265
        • Integrated Clinical Trial Services, Inc
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66210
        • International Clinical Research Institute, Inc.
    • Louisiana
      • Bossier City, Louisiana, Forenede Stater, 71111
        • Willis-Kinghton Physician Network / River Cities International Pain Specialist
      • Metairie, Louisiana, Forenede Stater, 70006
        • Clinical Trials Management, LLC
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Best Clinical Trials, LLC
      • Shreveport, Louisiana, Forenede Stater, 71105
        • River Cities Clinical Research Center
    • Massachusetts
      • Watertown, Massachusetts, Forenede Stater, 02472
        • MedVadis Research Corp.
    • Michigan
      • Bay City, Michigan, Forenede Stater, 48706
        • Great Lakes Research Group, Inc.
    • Mississippi
      • Biloxi, Mississippi, Forenede Stater, 39531
        • The Center for Clinical Trials
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Office of Robert Kaplan, DO
    • New Jersey
      • Berlin, New Jersey, Forenede Stater, 08009
        • Comprehensive Clinical Research
    • New York
      • Great Neck, New York, Forenede Stater, 11023
        • Long Island Gastrointestinal Research Group
      • Williamsville, New York, Forenede Stater, 14221
        • Upstate Clinical Research Associates
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27408
        • PharmQuest, LLC
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • The Center for Clinical Research
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58104
        • Plains Medical Clinic, LLC
    • Ohio
      • Beavercreek, Ohio, Forenede Stater, 45432
        • Clinical Inquest Center, LTD
      • Cincinnati, Ohio, Forenede Stater, 45242
        • New Horizons Health Research
      • Franklin, Ohio, Forenede Stater, 45005
        • Prestige Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73109
        • Health Research Institute
      • Oklahoma City, Oklahoma, Forenede Stater, 73109
        • Neuropsychiatric Research Center Research
    • Pennsylvania
      • Downingtown, Pennsylvania, Forenede Stater, 19335
        • Brandywine Clinical Research
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • Altoona Center For Clinical Research
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57702
        • Health Concepts
    • Texas
      • Austin, Texas, Forenede Stater, 78731
        • FutureSearch Clinical Trials
      • Dallas, Texas, Forenede Stater, 75230
        • KRK Medical Research
      • Dallas, Texas, Forenede Stater, 75231
        • Future Search Trials of Dallas, LP
      • Houston, Texas, Forenede Stater, 77074
        • Clinical Trial Network
      • Houston, Texas, Forenede Stater, 77062
        • Advanced Clinical Research of Houston
      • San Antonio, Texas, Forenede Stater, 78229
        • Innovative Clinical Trials
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Highland 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:

  • Diagnosis of moderate to severe low back pain for ≥6 months
  • Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed [PRN] analgesic rescue medications permitted on top of the stable daily maintenance dose of ≥30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)
  • Stable health, as determine by Principal Investigator
  • Females are practicing abstinence, using a medically acceptable form of contraception, or 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 within 6 months of screening
  • Subjects with 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 of any opioid or acetaminophen
  • Surgical procedure for relief of pain within 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

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Buprenorphin HCl Buccal Film
Dosering 2 gange dagligt
Medicin: Buprenorphine
Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily
Andre navne:
  • BEMA Buprenorphin
  • BELBUCA
  • EN3409
  • Buprenorphin HCl Buccal Film
Placebo komparator: Placebo Buccal Film
Twice Daily Dosing
Medicin: Placebo
Matchende placebo Buccal Film to gange dagligt
Andre navne:
  • Placebo Bucal Film
  • BEMA Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
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
Procentdel af deltagere med behandlingssvigt i den dobbeltblindede behandlingsfase (op til 12 uger)
Tidsramme: Baseline til behandlingssvigt eller afslutning af dobbeltblindet behandlingsfase (op til 12 uger)
Behandlingssvigt defineres som afbrydelse af undersøgelsen på grund af manglende effekt eller seponering på grund af uønskede hændelser i den dobbeltblindede behandlingsfase.
Baseline til behandlingssvigt eller afslutning af dobbeltblindet behandlingsfase (op til 12 uger)
Patients globale indtryk af forandring
Tidsramme: Uge 12
Forsøgspersoner vurderede deres ændring i aktivitetsbegrænsninger, da de forholder sig til deres smertefulde tilstand siden de påbegyndte behandling ved at bruge spørgeskemaet Patient Global Impression of Change (PGIC), en 7-punkts skala fra 1 (ingen ændring [eller tilstanden er blevet værre]) til 7 (en hel del bedre, og en betydelig forbedring, der gjorde hele forskellen)
Uge 12
Number of Participants With Response to Treatment (Responder) Using NRS Scale
Tidsramme: 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 numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Prior to open-label titration to week 12 in double-blind treatment
Number of Subjects With Opioid Rescue Medication Use
Tidsramme: Week 1 to Week 12
Use of analgesic rescue medication recorded in subject diary
Week 1 to Week 12
Time to Optimal Dose of Open-label Study Medication
Tidsramme: Up to 8 weeks in open-label titration
Overall time to reach the "optimum" dose of study medication required to progress to double-blind treatment
Up to 8 weeks in open-label titration
Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
Tidsramme: 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.
Baseline, week 12
Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale
Tidsramme: 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).
Baseline, Week 12
Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep
Tidsramme: 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 quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.
Week 12

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. september 2012

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

27. august 2012

Først indsendt, der opfyldte QC-kriterier

27. august 2012

Først opslået (Skøn)

29. august 2012

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

  • EN3409-307

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 .

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Sponsorer og samarbejdspartnere

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CROs by country

CROs in Sweden

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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