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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

547

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

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. december 2006

Primær færdiggørelse (Faktiske)

1. november 2007

Studieafslutning (Faktiske)

1. november 2007

Datoer for studieregistrering

Først indsendt

10. januar 2007

Først indsendt, der opfyldte QC-kriterier

10. januar 2007

Først opslået (Skøn)

11. januar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ALO-KNT-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 Slidgigt

Kliniske forsøg med ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Singapore

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner