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A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

13. september 2013 oppdatert av: Pfizer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee

The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.

Studietype

Intervensjonell

Registrering (Faktiske)

547

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, 35244
        • The Birmingham Pain Center
      • Mobile, Alabama, Forente stater, 36608
        • Horizon Research Group
    • Arizona
      • Peoria, Arizona, Forente stater, 85383
        • Arizona Center For Clinical Research
      • Phoenix, Arizona, Forente stater, 85023
        • Arizona Research Center, Inc
      • Tempe, Arizona, Forente stater, 85282
        • Premiere Pharmaceutical Research, LLC
    • California
      • Anaheim, California, Forente stater, 92801
        • Advanced Clinical Research Institute
      • Anaheim, California, Forente stater, 92801
        • Orange County Clinical Trials
      • Anaheim, California, Forente stater, 92804
        • STAT-CARE / Crest Clinical Trials
      • Buena Park, California, Forente stater, 90620
        • Southbay Pharma Research
      • Burbank, California, Forente stater, 91505
        • Providence Clinical Res. (C-trials)
      • Fair Oaks, California, Forente stater, 95628
        • Med Investigators Inc
      • Hawaiian Gardens, California, Forente stater, 90716
        • Quality of Life Medical Center, LLC
      • Irvine, California, Forente stater, 92618
        • NervePro Research
      • La Jolla, California, Forente stater, 92093
        • UCSD Pain and Palliative Care
      • La Jolla, California, Forente stater, 92093
        • USCD Pain and Palliative Care
      • Pico Rivera, California, Forente stater, 90660
        • Private practice
      • Santa Monica, California, Forente stater, 90404
        • Pain Institute of Santa Monica
      • Upland, California, Forente stater, 91786
        • Boling Clinical Trials
    • Colorado
      • Denver, Colorado, Forente stater, 80209
        • Mountain View Clinical Research, Inc
    • Connecticut
      • Stamford, Connecticut, Forente stater, 06905
        • Stamford Therapeutics Consortium
      • Trumbull, Connecticut, Forente stater, 06611
        • New England Research Associates, LLC
    • Florida
      • Hallandale Beach, Florida, Forente stater, 33009
        • MD Clinical
      • Hialeah, Florida, Forente stater, 33013
        • Eastern Research
      • Jacksonville, Florida, Forente stater, 32257
        • Florida Institute of Medical Research
      • Jupiter, Florida, Forente stater, 33458
        • Drug Study Institiute
      • Kissimmee, Florida, Forente stater, 34741
        • FPA Clinical Research
      • Largo, Florida, Forente stater, 33770
        • Innovative Research of West Florida
      • Merritt Island, Florida, Forente stater, 32953
        • Pharmaceutical Research Associates Inc
      • Ormond Beach, Florida, Forente stater, 32174
        • Ormond Medical Arts - Pharmaceutical Research Center
      • Pembroke Pines, Florida, Forente stater, 33024
        • University Clinical Research, Inc
      • Port Orange, Florida, Forente stater, 32127
        • Coastal Medical Research
      • Tampa, Florida, Forente stater, 33613
        • Stedman Clinical Trials
      • Weston, Florida, Forente stater, 33331
        • Gold Coast Research LLC
    • Georgia
      • Blue Ridge, Georgia, Forente stater, 30513
        • River Birch Research Alliance
      • Decatur, Georgia, Forente stater, 30034
        • Best Clinical Research
      • Marietta, Georgia, Forente stater, 30066
        • Drug Studies America
      • Marietta, Georgia, Forente stater, 30060
        • Non-Surgical Orthopaedic and Spine Center
    • Idaho
      • Boise, Idaho, Forente stater, 83704
        • Northwest Clinical Trials
    • Illinois
      • Peoria, Illinois, Forente stater, 61614
        • Research Associates of Central Illinois
    • Indiana
      • Evansville, Indiana, Forente stater, 47714
        • MediSphere Medical Research Center, LLC
      • Newburgh, Indiana, Forente stater, 47630
        • Welborn Clinic
    • Kansas
      • Overland Park, Kansas, Forente stater, 66211
        • International Clinical Research Institute, Inc
    • Louisiana
      • Mandeville, Louisiana, Forente stater, 70471
        • Clinical Trials Management, LLC
      • New Orleans, Louisiana, Forente stater, 70114
        • Lousiana Research Associates Inc.
    • Maryland
      • Towson, Maryland, Forente stater, 21286
        • Internal Research Center
    • Massachusetts
      • Fall River, Massachusetts, Forente stater, 02720
        • Phase III Clinical Research
      • No Dartmouth, Massachusetts, Forente stater, 02747
        • Northeast Medical Research Associates, Inc
      • Springfield, Massachusetts, Forente stater, 01107
        • FutureCare Studies
    • Michigan
      • Saginaw, Michigan, Forente stater, 48602
        • Synergy Medical Education Alliance
    • Missouri
      • St. Louis, Missouri, Forente stater, 63117
        • Medex Healthcare Research Inc
    • Nevada
      • Henderson, Nevada, Forente stater, 89014
        • Lovelace Scientific
      • Las Vegas, Nevada, Forente stater, 89123
        • Advanced Biomedical Research of America
    • New Jersey
      • Voorhees, New Jersey, Forente stater, 08043
        • Partners in Primary Care
    • New York
      • Mount Vernon, New York, Forente stater, 10550
        • Elkind Headache Center
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28210
        • The Arthritis Clinic and Carolina Bone and Joint
      • Winston-Salem, North Carolina, Forente stater, 27103
        • The Center for Clinical Research, LLC
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45227
        • Community Research
      • Cincinnati, Ohio, Forente stater, 45245
        • Community Research
      • Toledo, Ohio, Forente stater, 43551
        • Clinical Research Source, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73109
        • Health Research Institute
      • Oklahoma City, Oklahoma, Forente stater, 73116
        • Cutting Edge Research
      • Oklahoma City, Oklahoma, Forente stater, 73103
        • Cor Clinical Research
      • Tulsa, Oklahoma, Forente stater, 74101
        • Tulsa Clinical Research
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • LVH Neurosciences and Pain Research
      • Bensalem, Pennsylvania, Forente stater, 19020
        • Pennsylvania Research Institute
      • Duncansville, Pennsylvania, Forente stater, 16635
        • Altoona Center for Clinical Research
      • Fleetwood, Pennsylvania, Forente stater, 19522
        • Commonwealth Primary Care / Fleetwood Clinical Research
      • Souderton, Pennsylvania, Forente stater, 18964
        • Pivotal Clinical Research, Llc
      • Tipton, Pennsylvania, Forente stater, 16684
        • Tipton Medical and Diagnostic Center
    • Tennessee
      • Clarksville, Tennessee, Forente stater, 37043
        • Premier Medical Group
      • Cordova, Tennessee, Forente stater, 38018
        • SCRI
      • Hendersonville, Tennessee, Forente stater, 37075
        • Comprehensive Pain Specialists
      • Memphis, Tennessee, Forente stater, 38119
        • SCRI
      • Milan, Tennessee, Forente stater, 38358
        • Integrity Clinical Research, LLC
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Walter F. Chase, MD, PA
      • DeSoto, Texas, Forente stater, 75115
        • Insite clinical research
      • Killeen, Texas, Forente stater, 76543
        • Team Research of Central Texas
      • San Antonio, Texas, Forente stater, 78229
        • Progressive Clinical Research
      • San Antonio, Texas, Forente stater, 78218
        • North San Antonio Healthcare Associates
      • San Antonio, Texas, Forente stater, 78217
        • Radiant Research, San Antonio Northeast
    • Virginia
      • Roanoke, Virginia, Forente stater, 24018
        • HypotheTest, LLC

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

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subject is 21 years of age or older
  • Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
  • Negative pregnancy test if female of childbearing potential
  • Subject is in general good health
  • Subject required treatment of joint pain within the last 90 days
  • Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee

Exclusion Criteria:

  • Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
  • Subject is pregnant or breast-feeding
  • Subject is receiving systemic chemotherapy
  • Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
  • Subject has history of major depressive disorder not controlled with medication
  • Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
  • Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)
  • Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis

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: ALO-01
Up to 80 mg twice a day (bid)
Legemiddel: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
capsules, up to 80 mg bid
Andre navn:
  • Embeda
Placebo komparator: Placebo
Twice a day (bid)
Legemiddel: Placebo
capsules, bid

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)
Tidsramme: randomization to 12 weeks following randomization
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
randomization to 12 weeks following randomization

Samarbeidspartnere og etterforskere

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

Sponsor

Pfizer

Etterforskere

  • Studieleder: James B. Jones, MD, PharmD, Alpharma Pharmceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. desember 2006

Primær fullføring (Faktiske)

1. november 2007

Studiet fullført (Faktiske)

1. november 2007

Datoer for studieregistrering

Først innsendt

10. januar 2007

Først innsendt som oppfylte QC-kriteriene

10. januar 2007

Først lagt ut (Anslag)

11. januar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. september 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. september 2013

Sist bekreftet

1. september 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ALO-KNT-301

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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