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

12. januar 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

815

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Buprenorphine HCl Buccal Film
Dosering to ganger daglig
Legemiddel: Buprenorphine
Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily
Andre navn:
  • BEMA buprenorfin
  • BELBUCA
  • EN3409
  • Buprenorphine HCl Buccal Film
Placebo komparator: Placebo Buccal Film
Twice Daily Dosing
Legemiddel: Placebo
Matchende Placebo Buccal Film to ganger daglig
Andre navn:
  • Placebo Bucal Film
  • BEMA Placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Prosentandel av deltakere med behandlingssvikt i den dobbeltblindede behandlingsfasen (opptil 12 uker)
Tidsramme: Grunnlinje til behandlingssvikt eller slutten av dobbeltblind behandlingsfase (opptil 12 uker)
Behandlingssvikt er definert som seponering av studien på grunn av manglende effekt eller seponering på grunn av uønskede hendelser i den dobbeltblinde behandlingsfasen.
Grunnlinje til behandlingssvikt eller slutten av dobbeltblind behandlingsfase (opptil 12 uker)
Pasientens globale inntrykk av endring
Tidsramme: Uke 12
Forsøkspersonene vurderte deres endring i aktivitetsbegrensninger når de forholder seg til deres smertefulle tilstand siden de begynte behandlingen ved å bruke spørreskjemaet Patient Global Impression of Change (PGIC), en 7-punkts skala som strekker seg fra 1 (ingen endring [eller tilstanden har blitt verre]) til 7 (mye bedre, og en betydelig forbedring som gjorde hele forskjellen)
Uke 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

BioDelivery Sciences International

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2012

Primær fullføring (Faktiske)

1. juni 2014

Studiet fullført (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først innsendt

27. august 2012

Først innsendt som oppfylte QC-kriteriene

27. august 2012

Først lagt ut (Anslag)

29. august 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EN3409-307

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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