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Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

27. august 2012 opdateret af: Purdue Pharma LP

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

529

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
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85206
        • Vista Medical Research
      • Phoenix, Arizona, Forenede Stater, 85023
        • Arizona Research Center
      • Phoenix, Arizona, Forenede Stater, 85013
        • Radiant Research
      • Phoenix, Arizona, Forenede Stater, 85012
        • Arizona Research Center
      • Tucson, Arizona, Forenede Stater, 85715
        • ACRC/Arizona Clinical Research
    • California
      • Bakersfield, California, Forenede Stater, 93311
        • Advance Pain Medicine
      • Cypress, California, Forenede Stater, 90623
        • Eastgate Medical Center
      • Loma Linda, California, Forenede Stater, 92354
        • University Osteoporosis Ctr
      • San Diego, California, Forenede Stater, 92108
        • San Diego Arthritis & Osteoporosis Medical Clinic
      • San Diego, California, Forenede Stater, 92128
        • Scripps Clinic Rancho Bernard
      • San Francisco, California, Forenede Stater, 94121
        • CNS Clinical Trials, Inc
    • Colorado
      • Denver, Colorado, Forenede Stater, 80209
        • Mountain View Clinical Research
      • Westminster, Colorado, Forenede Stater, 80021
        • Integrative Treatment Centers/Rocky Mtn Clin Res
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Rocky Mountain Center for Clinical Research
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater, 66060
        • Stamford Therapeutic Consortium
    • Florida
      • Atlantis, Florida, Forenede Stater, 33462
        • Medical Specialists of the Palm Beaches
      • Deland, Florida, Forenede Stater, 32720
        • University Clinical Research Deland
      • Jupiter, Florida, Forenede Stater, 33458
        • Drug Study Institute
      • Orange City, Florida, Forenede Stater, 32763
        • Coastal Medical Research
      • Port Orange, Florida, Forenede Stater, 32127
        • Coastal Medical Research
      • W. Palm Beach, Florida, Forenede Stater, 33409
        • Palm Beach Research Center
      • Weston, Florida, Forenede Stater, 33331
        • Gold Coast Research
    • Georgia
      • Marietta, Georgia, Forenede Stater, 30060
        • Non-Surgical Orthopedic & Spine Center
    • Indiana
      • Columbus, Indiana, Forenede Stater, 47201
        • Columbus Internal Medical Associates
      • Evansville, Indiana, Forenede Stater, 47714
        • MediSphere Medical Research Ctr.
    • Kentucky
      • Murray, Kentucky, Forenede Stater, 42071
        • Primary Care Research
    • Michigan
      • Cadillac, Michigan, Forenede Stater, 49601
        • Professional Clinical Research
      • Traverse City, Michigan, Forenede Stater, 49684
        • Sound Medical At West Front Primary Care
    • New York
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • All-Trials Clinical Research, LLC
    • Pennsylvania
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • Keystone Clinical
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • Altoona Center for Clinical Research
      • State College, Pennsylvania, Forenede Stater, 16801
        • University Orthopedics Center
      • West Reading, Pennsylvania, Forenede Stater, 19611
        • Clinical Research Center of Reading, LLP
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406
        • Low Country Rheumatology
    • South Dakota
      • Watertown, South Dakota, Forenede Stater, 57201
        • Brown Clinic
    • Texas
      • Dallas, Texas, Forenede Stater, 75251
        • Private Practice
      • Harker Heights, Texas, Forenede Stater, 76548
        • Team Research of Central Texas
      • San Antonio, Texas, Forenede Stater, 78217
        • Radiant Research San Antonio Northeast
      • Seguin, Texas, Forenede Stater, 78155
        • ACCU Clinical Research Trials, Inc
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Wasatch Clinical Research
    • Virginia
      • Virgina Beach, Virginia, Forenede Stater, 23454
        • Advance Pain Management & Rehab
    • Washington
      • Edmonds, Washington, Forenede Stater, 98026
        • Evergreen Clinical Research Associates
      • Tacoma, Washington, Forenede Stater, 98405
        • Internal Medicine Northwest

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

40 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
  • an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.

Exclusion Criteria:

  • ingest opioid analgesics on a daily basis.
  • ingest >2500 milligrams (mg) acetaminophen on a daily basis.
  • require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.

Other protocol-specific exclusion/inclusion criteria may apply.

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: BTDS
Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h)
Medicin: Buprenorphin depotplaster
Buprenorphin depotplaster 5, 10 eller 20 mcg/t påført til 7-dages brug.
Andre navne:
  • Butrans™
Placebo komparator: Placebo
Placebo to match BTDS 5, 10 or 20 mcg/h
Medicin: Placebo
Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
Tidsramme: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods

Inadequate analgesia:

  • "average pain over the last 24 hours" score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;
  • >1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;
  • ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia.
Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site
Tidsramme: 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.
The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. "Pain right now" scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).
7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.

Samarbejdspartnere og efterforskere

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

Sponsor

Purdue Pharma LP

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.

Hjælpsomme links

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. april 2003

Primær færdiggørelse (Faktiske)

1. juni 2004

Studieafslutning (Faktiske)

1. juni 2004

Datoer for studieregistrering

Først indsendt

11. april 2006

Først indsendt, der opfyldte QC-kriterier

11. april 2006

Først opslået (Skøn)

12. april 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. september 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2012

Sidst verificeret

1. august 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BUP3012

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 Buprenorphin depotplaster

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malta

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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