Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee

19. marts 2009 opdateret af: IDEA AG

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Doses of IDEA-033 in Comparison to Oral Naproxen for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee

The purpose of this study is to identify the dose(s) of IDEA-033 that will provide a meaningful effect for treating osteoarthritis of the knee.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The objective of this double-blind, placebo-controlled, randomized study is to evaluate the safety of and to identify the dose(s) of IDEA-033 that will provide a minimum clinically meaningful effect for treating the signs and symptoms of osteoarthritis of the knee. This study will also compare the safety profile of the three doses of IDEA-033 in treating the signs and symptoms associated with osteoarthritis for 12 weeks. The primary hypothesis is that at least one of the three doses of IDEA-033 is superior to placebo with respect to three primary efficacy endpoints of WOMAC Pain, WOMAC Physical Function, and Subject Global Assessment of Response to Therapy. A second hypothesis is that there is an increase in efficacy with increasing doses of IDEA-033.

Patients will receive one of five treatments for 12 weeks:Three doses of IDEA-033, or naproxen 1 g over-encapsulated tablet + placebo or placebo

Undersøgelsestype

Interventionel

Tilmelding

875

Fase

  • Fase 2

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, 35209
      • Montgomery, Alabama, Forenede Stater, 36101
      • Montgomery, Alabama, Forenede Stater, 36124
        • Drug Research and Analysis Corporation
      • Northport, Alabama, Forenede Stater, 35476
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85206
      • Phoenix, Arizona, Forenede Stater, 85032
      • Tempe, Arizona, Forenede Stater, 85258
    • California
      • Anaheim, California, Forenede Stater, 92801
      • Encinitas, California, Forenede Stater, 92024
      • Fair Oaks, California, Forenede Stater, 95628
      • Garden Grove, California, Forenede Stater, 92840
      • Irvine, California, Forenede Stater, 92618
      • Paramount, California, Forenede Stater, 90723
      • Rancho Mirage, California, Forenede Stater, 92270
      • San Diego, California, Forenede Stater, 92120
      • Spring Valley, California, Forenede Stater, 91978
      • Temecula, California, Forenede Stater, 92591
      • Vista, California, Forenede Stater, 92083
    • Colorado
      • Northglenn, Colorado, Forenede Stater, 80234
    • Connecticut
      • Danbury, Connecticut, Forenede Stater, 06810
    • Florida
      • Clearwater, Florida, Forenede Stater, 33761
      • Coral Gables, Florida, Forenede Stater, 33134
      • Daytona Beach, Florida, Forenede Stater, 32114
      • Deland, Florida, Forenede Stater, 32720
      • Fort Lauderdale, Florida, Forenede Stater, 33334
      • Fort Myers, Florida, Forenede Stater, 33916
      • Gainesville, Florida, Forenede Stater, 32607
      • Hialeah, Florida, Forenede Stater, 33013
      • Jacksonville, Florida, Forenede Stater, 32216
      • Ocala, Florida, Forenede Stater, 34474
      • Ocala, Florida, Forenede Stater, 34471
      • Ocoee, Florida, Forenede Stater, 34761
      • Palm Harbor, Florida, Forenede Stater, 34684
      • Pembroke Pines, Florida, Forenede Stater, 33024
      • Port Orange, Florida, Forenede Stater, 32127
      • Tampa, Florida, Forenede Stater, 33614
      • West Palm Beach, Florida, Forenede Stater, 33409
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
      • Atlanta, Georgia, Forenede Stater, 30329
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47714
    • Kansas
      • Arkansas City, Kansas, Forenede Stater, 67005
      • Kansas City, Kansas, Forenede Stater, 66109
      • Newton, Kansas, Forenede Stater, 67114
      • Wichita, Kansas, Forenede Stater, 67205
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40291
    • Maryland
      • Towson, Maryland, Forenede Stater, 21286
    • Massachusetts
      • Milford, Massachusetts, Forenede Stater, 01757
    • Michigan
      • East Lansing, Michigan, Forenede Stater, 48910
      • Kalamazoo, Michigan, Forenede Stater, 49009
      • Lansing, Michigan, Forenede Stater, 48917
    • Mississippi
      • Flowood, Mississippi, Forenede Stater, 39232
      • Jackson, Mississippi, Forenede Stater, 39202
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 00000
    • Montana
      • Bozeman, Montana, Forenede Stater, 59715
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
    • New Jersey
      • Berlin, New Jersey, Forenede Stater, 08009
      • Dover, New Jersey, Forenede Stater, 07801
    • New York
      • Binghamton, New York, Forenede Stater, 13901
      • Manilus, New York, Forenede Stater, 13104
      • Rochester, New York, Forenede Stater, 14609
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27704
      • Fayetteville, North Carolina, Forenede Stater, 28304
        • Cumberland Research Associates L L C
      • Wilmington, North Carolina, Forenede Stater, 28412
      • Winston Salem, North Carolina, Forenede Stater, 27103
    • Ohio
      • Cincinatti, Ohio, Forenede Stater, 45227
        • Community Research Managment Associates
      • Cincinnati, Ohio, Forenede Stater, 45219
      • Cincinnati, Ohio, Forenede Stater, 45236
      • Cincinnati, Ohio, Forenede Stater, 45224
      • Colombus, Ohio, Forenede Stater, 43215
      • Columbus, Ohio, Forenede Stater, 43212
      • Franklin, Ohio, Forenede Stater, 45005
      • Perrysburg, Ohio, Forenede Stater, 43551
    • Oklahoma
      • Bethany, Oklahoma, Forenede Stater, 73008
    • Pennsylvania
      • Beaver, Pennsylvania, Forenede Stater, 15009
      • Bensalem, Pennsylvania, Forenede Stater, 19020
      • Duncansville, Pennsylvania, Forenede Stater, 16635
      • Harleysville, Pennsylvania, Forenede Stater, 19438
      • Levittown, Pennsylvania, Forenede Stater, 19057
      • Penndel, Pennsylvania, Forenede Stater, 19047
      • Philadelphia, Pennsylvania, Forenede Stater, 19152
      • Pittsburgh, Pennsylvania, Forenede Stater, 15219
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
      • Charleston, South Carolina, Forenede Stater, 29407
      • Columbia, South Carolina, Forenede Stater, 29204
      • Greer, South Carolina, Forenede Stater, 29651
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
    • Texas
      • Austin, Texas, Forenede Stater, 78758
      • Dallas, Texas, Forenede Stater, 75231
      • Dallas, Texas, Forenede Stater, 75234
      • Dallas, Texas, Forenede Stater, 75235
      • Houston, Texas, Forenede Stater, 77024
      • Lake Jackson, Texas, Forenede Stater, 77566
      • San Antonio, Texas, Forenede Stater, 78217
      • San Antonio, Texas, Forenede Stater, 78209
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84124
      • Salt Lake City, Utah, Forenede Stater, 84102
    • Washington
      • Spokane, Washington, Forenede Stater, 99202
      • Spokane, Washington, Forenede Stater, 99207
    • Wisconsin
      • Glendale, Wisconsin, Forenede Stater, 53217

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:

  • Osteoarthritis of both knees for minimum of six months
  • Moderate pain in the most involved knee when not taking NSAIDs
  • Must have used an oral NSAID on at least three days per week for last three months or 25 of 30 days before screening
  • Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months

Exclusion Criteria:

  • Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
  • Intra-articular injections or arthroscopy of the most involved knee during three months before Screening visit
  • Inflammation of the most involved knee that could be related to gout or pseudogout-induced synovitis or infection
  • A large bulging effusion
  • History of gout or pseudo-gout induced synovitis or infection of the more severe knee
  • History of partial or total knee replacement in either knee

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Change from baseline at Week 12 on pain subscale and physical function subscale on the WOMAC Osteoarthritis Index. Subject global assessment of response to therapy (SGART) on a five-point Likert scale at Week 12.

Sekundære resultatmål

Resultatmål
Change from baseline at Weeks 2, 6, 9 for WOMAC pain and physical function scores and SGART. Mean change from baseline for the entire on-therapy period for WOMAC pain and physical function scores and SGART.

Samarbejdspartnere og efterforskere

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

Sponsor

IDEA AG

Efterforskere

  • Studieleder: IDEA AG Clinical Trial, IDEA AG

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. juni 2005

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier

13. september 2005

Først opslået (Skøn)

21. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. marts 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. marts 2009

Sidst verificeret

1. marts 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CL-033-III-04

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, knæ

Kliniske forsøg med IDEA-033

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Equatorial Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner