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En sammenligning af dosis én gang om dagen sammenlignet med 2 doser om dagen

15. april 2013 opdateret af: Warner Chilcott

Et multicenter, investigator-blindet, randomiseret, 12-måneders, parallel-gruppe, non-inferioritetsstudie for at sammenligne effektiviteten af ​​1,6 til 2,4 g Asacol® terapi QD versus divideret dosis (BID) i opretholdelse af remission af colitis ulcerosa

Formålet med denne undersøgelse er at sammenligne effektiviteten til at opretholde remission af colitis ulcerosa mellem et Asacol-regimen én gang dagligt (QD) og et opdelt, to gange dagligt (BID) Asacol-doseringsregimen.

Studieoversigt

Detaljeret beskrivelse

I USA er Asacol-behandling i øjeblikket indiceret i opdelte doser til opretholdelse af remission af colitis ulcerosa med 1,6 g/dag. En dosis én gang dagligt er potentielt gavnlig for både patienter og læger. Denne undersøgelse vil besvare følgende spørgsmål om dosering én gang dagligt: ​​(1) adskiller effektiviteten sig mellem én gang daglig og to gange daglig dosering, (2) foretrækker patienter en én gang daglig dosering, og (3) er compliance bedre? Denne undersøgelse vil bekræfte, om der er fordele ved dosering én gang dagligt ud over øget bekvemmelighed. For at forstå, hvordan QD-kuren kan sammenlignes med BID i et "virkelig liv" praksis, vil patienten forblive på den samlede daglige dosis af Asacol (1,6 g/dag til 2,4 g/dag), hvor de blev holdt i remission, men vil blive tildelt enten en QD- eller BID-kur. Dette er en efterforsker-blindet undersøgelse.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1027

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Quebec, Canada, G1L 3L5
        • Research Facility
      • Quebec, Canada, G1S 4L8
        • Research Facility
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
        • Research Facility
    • Ontario
      • Guelph, Ontario, Canada, N1H 3R3
        • Research Facility
      • Hamilton, Ontario, Canada, L8N 4A6
        • Research Facility
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Facility
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Facility
      • Toronto, Ontario, Canada, M5G 2O4
        • Research Facility
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Facility
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Facility
    • Alabama
      • Athens, Alabama, Forenede Stater, 35611
        • Research Facility
      • Birmingham, Alabama, Forenede Stater, 35209
        • Research Facility
      • Birmingham, Alabama, Forenede Stater, 35294
        • Research Facility
      • Dothan, Alabama, Forenede Stater, 26305-1156
        • Research Facility
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85050
        • Research Facility
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Research Facility
      • Tucson, Arizona, Forenede Stater, 85712
        • Research Facility
      • Tuscon, Arizona, Forenede Stater, 85711
        • Research Facility
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Research Facility
      • Lowell, Arkansas, Forenede Stater, 72745
        • Research Facility
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Research Facility
      • Beverly Hills, California, Forenede Stater, 90210
        • Research Facility
      • Chico, California, Forenede Stater, 95926
        • Research Facility
      • Encinitas, California, Forenede Stater, 92024
        • Research Facility
      • Folsum, California, Forenede Stater, 95630
        • Research Facility
      • La Mesa, California, Forenede Stater, 91941
        • Research Facility
      • Lancaster, California, Forenede Stater, 93534
        • Research Facility
      • Long Beach, California, Forenede Stater, 90806
        • Research Facility
      • Los Angeles, California, Forenede Stater, 90015
        • Research Facility
      • Los Angeles, California, Forenede Stater, 90045
        • Research Facility
      • Madera, California, Forenede Stater, 93637
        • Research Facility
      • Merced, California, Forenede Stater, 95340
        • Research Facility
      • Mission Hills, California, Forenede Stater, 91345
        • Research Facility
      • Monterey, California, Forenede Stater, 93940
        • Research Facility
      • Murrieta, California, Forenede Stater, 92562
        • Research Facility
      • Oakland, California, Forenede Stater, 94609
        • Research Facility
      • Orange, California, Forenede Stater, 92868
        • Research Facility
      • Palm Springs, California, Forenede Stater, 92262
        • Research Facility
      • San Carlos, California, Forenede Stater, 94070
        • Research Facility
      • San Diego, California, Forenede Stater, 92123
        • Research Facility
      • San Diego, California, Forenede Stater, 92103
        • Research Facility
      • San Diego, California, Forenede Stater, 92117
        • Research Facility
      • San Francisco, California, Forenede Stater, 94117
        • Research Facility
      • San Francisco, California, Forenede Stater, 94122
        • Research Facility
      • Torrance, California, Forenede Stater, 90503
        • Research Facility
      • Torrance, California, Forenede Stater, 90505
        • Research Facility
      • Upland, California, Forenede Stater, 91786
        • Research Facility
    • Colorado
      • Englewood, Colorado, Forenede Stater, 80113
        • Research Facility
      • Golden, Colorado, Forenede Stater, 80401
        • Research Facility
      • Lafayette, Colorado, Forenede Stater, 80026
        • Research Facility
      • Pueblo, Colorado, Forenede Stater, 81008
        • Research Facility
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Research Facility
      • Meriden, Connecticut, Forenede Stater, 06451
        • Research Facility
      • New Haven, Connecticut, Forenede Stater, 06510
        • Research Facility
      • Norwalk, Connecticut, Forenede Stater, 06851
        • Research Facility
      • Torrington, Connecticut, Forenede Stater, 06790
        • Research Facility
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20060
        • Research Facility
    • Florida
      • Aventura, Florida, Forenede Stater, 33180
        • Research Facility
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Research Facility
      • Gainesville, Florida, Forenede Stater, 32607
        • Research Facility
      • Hollywood, Florida, Forenede Stater, 33021
        • Research Facility
      • Jacksonville, Florida, Forenede Stater, 32207
        • Research Facility
      • Jacksonville, Florida, Forenede Stater, 32223
        • Research Facility
      • Largo, Florida, Forenede Stater, 33777
        • Research Facility
      • Maitland, Florida, Forenede Stater, 32751
        • Research Facility
      • Naples, Florida, Forenede Stater, 34102
        • Research Facility
      • New Port Richey, Florida, Forenede Stater, 34652
        • Research Facility
      • North Miami Beach, Florida, Forenede Stater, 33162
        • Research Facility
      • Orlando, Florida, Forenede Stater, 32806
        • Research Facility
      • Palm Harbor, Florida, Forenede Stater, 34684
        • Research Facility
      • Port Orange, Florida, Forenede Stater, 32129
        • Research Facility
      • St Petersburg, Florida, Forenede Stater, 33711
        • Research Facility
      • St. Petersburg, Florida, Forenede Stater, 33707
        • Research Facility
      • Tallahassee, Florida, Forenede Stater, 32308
        • Research Facility
      • Tampa, Florida, Forenede Stater, 33613
        • Research Facility
      • Tampa, Florida, Forenede Stater, 33607
        • Research Facility
      • Trinity, Florida, Forenede Stater, 34655
        • Research Facility
      • Winter Park, Florida, Forenede Stater, 32789
        • Research Facility
      • Zephyrhills, Florida, Forenede Stater, 33542
        • Research Facility
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342-5000
        • Research Facility
      • Columbus, Georgia, Forenede Stater, 31904
        • Research Facility
      • Decatur, Georgia, Forenede Stater, 30033
        • Research Facility
      • Marietta, Georgia, Forenede Stater, 30060
        • Research Facility
      • Marietta, Georgia, Forenede Stater, 30067
        • Research Facility
      • Newnan, Georgia, Forenede Stater, 30263
        • Research Facility
      • Savannah, Georgia, Forenede Stater, 31406
        • Research Facility
    • Idaho
      • Boise, Idaho, Forenede Stater, 83704
        • Research Facility
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Research Facility
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60005
        • Research Facility
      • Berwyn, Illinois, Forenede Stater, 60402
        • Research Facility
      • Chicago, Illinois, Forenede Stater, 60637
        • Research Facility
      • Elgin, Illinois, Forenede Stater, 60123
        • Research Facility
      • Highland Park, Illinois, Forenede Stater, 60036
        • Research Facility
      • Hoffman Estates, Illinois, Forenede Stater, 60169
        • Research Facility
      • Homewood, Illinois, Forenede Stater, 60430
        • Research Facility
      • Lake Barrington, Illinois, Forenede Stater, 60010
        • Research Facility
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Research Facility
      • Peoria, Illinois, Forenede Stater, 61602
        • Research Facility
      • Urbana, Illinois, Forenede Stater, 61801
        • Research Facility
    • Indiana
      • Anderson, Indiana, Forenede Stater, 46016
        • Research Facility
      • Bloomington, Indiana, Forenede Stater, 47403
        • Research Facility
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Research Facility
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Research Facility
      • South Bend, Indiana, Forenede Stater, 46601
        • Research Facility
    • Iowa
      • Clive, Iowa, Forenede Stater, 50325
        • Research Facility
      • Davenport, Iowa, Forenede Stater, 52807
        • Research Facility
      • Waterloo, Iowa, Forenede Stater, 50701
        • Research Facility
    • Kansas
      • Pratt, Kansas, Forenede Stater, 67124
        • Research Facility
      • Topeka, Kansas, Forenede Stater, 66606
        • Research Facility
      • Whichita, Kansas, Forenede Stater, 67214
        • Research Site
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater, 42101
        • Research Facility
      • Louisville, Kentucky, Forenede Stater, 40202
        • Research Facility
      • Louisville, Kentucky, Forenede Stater, 40291
        • Research Facility
    • Louisiana
      • Alexandria, Louisiana, Forenede Stater, 71301
        • Research Facility
      • Lafayette, Louisiana, Forenede Stater, 70503
        • Research Facility
      • Metairie, Louisiana, Forenede Stater, 70006
        • Research Facility
      • Monroe, Louisiana, Forenede Stater, 71201
        • Research Facility
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Research Facility
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Research Facility
    • Maryland
      • Chevy Chase, Maryland, Forenede Stater, 20815
        • Research Facility
      • College Park, Maryland, Forenede Stater, 20740
        • Research Facility
      • Greenbelt, Maryland, Forenede Stater, 20770
        • Research Facility
      • Hagerstown, Maryland, Forenede Stater, 21740
        • Research Facility
      • Hollywood, Maryland, Forenede Stater, 20636
        • Research Facility
      • Lutherville, Maryland, Forenede Stater, 21093
        • Research Facility
      • Reisterstown, Maryland, Forenede Stater, 21136
        • Research Facility
      • Rockville, Maryland, Forenede Stater, 20850
        • Research Facility
      • Rockville, Maryland, Forenede Stater, 20854
        • Research Facility
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Research Facility
      • Boston, Massachusetts, Forenede Stater, 02215
        • Research Facility
      • Braintree, Massachusetts, Forenede Stater, 02184
        • Research Facility
      • Southbridge, Massachusetts, Forenede Stater, 01550
        • Research Facility
    • Michigan
      • Chesterfield, Michigan, Forenede Stater, 48047
        • Research Facility
      • Detroit, Michigan, Forenede Stater, 48201
        • Research Facility
      • Kalamazoo, Michigan, Forenede Stater, 49048
        • Research Facility
      • Troy, Michigan, Forenede Stater, 48098
        • Research Facility
      • West Bloomfied, Michigan, Forenede Stater, 48322
        • Research Facility
      • Wyoming, Michigan, Forenede Stater, 49519
        • Research Facility
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Research Facility
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Research Facility
    • Missouri
      • Cape Girardeau, Missouri, Forenede Stater, 63703-6364
        • Research Facility
      • Columbia, Missouri, Forenede Stater, 65212
        • Research Facility
      • Jefferson City, Missouri, Forenede Stater, 65109
        • Research Facility
      • Mexico, Missouri, Forenede Stater, 65265
        • Research Facility
      • St Louis, Missouri, Forenede Stater, 63128
        • Research Facility
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89147
        • Research Facility
    • New Hampshire
      • Somersworth, New Hampshire, Forenede Stater, 03878
        • Research Facility
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Research Facility
      • Cedar Knolls, New Jersey, Forenede Stater, 07927
        • Research Facility
      • Egg Harbor Township, New Jersey, Forenede Stater, 08234-5857
        • Research Facility
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Research Site
      • Ocean, New Jersey, Forenede Stater, 07712
        • Research Facility
      • South Plainfield, New Jersey, Forenede Stater, 07080
        • Research Facility
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • Research Facility
    • New York
      • Babylon, New York, Forenede Stater, 11702
        • Research Facility
      • Binghamton, New York, Forenede Stater, 13903
        • Research Facility
      • Brooklyn, New York, Forenede Stater, 11215
        • Research Facility
      • Brooklyn, New York, Forenede Stater, 11234
        • Research Facility
      • Cheektowaga, New York, Forenede Stater, 14225
        • Research Facility
      • Cortland, New York, Forenede Stater, 13045
        • Research Facility
      • Forest Hills, New York, Forenede Stater, 10128
        • Research Facility
      • Garden City, New York, Forenede Stater, 11530
        • Research Facility
      • Great Neck, New York, Forenede Stater, 11021
        • Research Facility
      • Great Neck, New York, Forenede Stater, 11023
        • Research Facility
      • Lake Success, New York, Forenede Stater, 11042
        • Research Facility
      • New York, New York, Forenede Stater, 10016
        • Research Facility
      • New York, New York, Forenede Stater, 10028
        • Research Facility
      • Pittsford, New York, Forenede Stater, 14534
        • Research Facility
      • Port Jefferson Station, New York, Forenede Stater, 11776
        • Research Facility
      • Rochester, New York, Forenede Stater, 14621
        • Research Facility
      • Rochester, New York, Forenede Stater, 14625
        • Research Facility
    • North Carolina
      • Boone, North Carolina, Forenede Stater, 28607
        • Research Facility
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Research Facility
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Research Facility
      • Greenville, North Carolina, Forenede Stater, 27834
        • Research Facility
      • Jacksonville, North Carolina, Forenede Stater, 28546
        • Research Facility
      • Kinston, North Carolina, Forenede Stater, 28501
        • Research Facility
      • Morganton, North Carolina, Forenede Stater, 28655
        • Research Facility
      • Mt Airy, North Carolina, Forenede Stater, 27030
        • Research Facility
      • Newbern, North Carolina, Forenede Stater, 28562
        • Research Facility
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • Research Facility
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Research Facility
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Research Facility
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Research Facility
    • Ohio
      • Akron, Ohio, Forenede Stater, 44302
        • Research Facility
      • Canton, Ohio, Forenede Stater, 44718
        • Research Facility
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Research Facility
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Research Facility
      • Cleveland, Ohio, Forenede Stater, 44195
        • Research Facility
      • Dayton, Ohio, Forenede Stater, 45440
        • Research Facility
      • Dayton, Ohio, Forenede Stater, 45415
        • Research Facility
      • Mentor, Ohio, Forenede Stater, 44060
        • Research Facility
      • Toledo, Ohio, Forenede Stater, 43617
        • Research Facility
      • Westlake, Ohio, Forenede Stater, 44145
        • Research Facility
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Research Facility
    • Oregon
      • Portland, Oregon, Forenede Stater, 97225
        • Research Facility
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18104
        • Research Facility
      • Beaver Falls, Pennsylvania, Forenede Stater, 15010
        • Research Facility
      • Clairton, Pennsylvania, Forenede Stater, 15025
        • Research Facility
      • Indiana, Pennsylvania, Forenede Stater, 15701
        • Research Facility
      • Lancaster, Pennsylvania, Forenede Stater, 17604
        • Research Facility
      • Philadelphia, Pennsylvania, Forenede Stater, 19106
        • Research Facility
      • Phoenixville, Pennsylvania, Forenede Stater, 19460
        • Research Facility
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Research Facility
      • Pittsburgh, Pennsylvania, Forenede Stater, 15243
        • Research Facility
      • Sewickley, Pennsylvania, Forenede Stater, 15143
        • Research Facility
      • Souderton, Pennsylvania, Forenede Stater, 18964
        • Research Facility
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • Research Facility
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02888
        • Research Facility
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Research Facility
      • Columbia, South Carolina, Forenede Stater, 29204
        • Research Facility
      • Greer, South Carolina, Forenede Stater, 29651
        • Research Facility
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38301
        • Research Facility
      • Jackson, Tennessee, Forenede Stater, 38305
        • Research Facility
      • Memphis, Tennessee, Forenede Stater, 38104
        • Research Facility
      • Morristown, Tennessee, Forenede Stater, 37814
        • Research Facility
    • Texas
      • Amarillo, Texas, Forenede Stater, 79119
        • Research Facility
      • Fort Worth, Texas, Forenede Stater, 76104
        • Research Facility
      • Greenville, Texas, Forenede Stater, 75401
        • Research Facility
      • Houston, Texas, Forenede Stater, 77054
        • Research Facility
      • Houston, Texas, Forenede Stater, 77004
        • Research Facility
      • Houston, Texas, Forenede Stater, 77090
        • Research Facility
      • Lewisville, Texas, Forenede Stater, 75057
        • Research Facility
      • Longview, Texas, Forenede Stater, 75605
        • Research Facility
      • Odessa, Texas, Forenede Stater, 79761
        • Research Facility
      • Pasadena, Texas, Forenede Stater, 77504
        • Research Facility
      • Plano, Texas, Forenede Stater, 75075
        • Research Facility
      • San Antonio, Texas, Forenede Stater, 78229
        • Research Facility
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Research Facility
      • Salt Lake City, Utah, Forenede Stater, 84107
        • Research Facility
      • West Valley City, Utah, Forenede Stater, 84120
        • Research Facility
    • Virginia
      • Alexandria, Virginia, Forenede Stater, 22306
        • Research Facility
      • Chesapeake, Virginia, Forenede Stater, 23320
        • Research Facility
      • Fairfax, Virginia, Forenede Stater, 22031
        • Research Facility
      • Norfolk, Virginia, Forenede Stater, 23502
        • Research Facility
      • Virginia Beach, Virginia, Forenede Stater, 23454
        • Research Facility
      • Winchester, Virginia, Forenede Stater, 22601
        • Research Facility
    • Washington
      • Seattle, Washington, Forenede Stater, 98133
        • Research Facility
      • Spokane, Washington, Forenede Stater, 99204
        • Research Facility
      • Tacoma, Washington, Forenede Stater, 98405
        • Research Facility
      • Wenatchee, Washington, Forenede Stater, 98801
        • Research Facility
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Research Facility
      • Monroe, Wisconsin, Forenede Stater, 53566
        • Research Facility
      • Ponce, Puerto Rico, 00717
        • Research Facility
      • San Juan, Puerto Rico, 00936
        • Research Facility

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

Inklusionskriterier:

  • Dokumenteret historie med colitis ulcerosa, der med succes er blevet holdt i remission i mindst 3 måneder før studiestart
  • Mindst én udbrud inden for de seneste 18 måneder
  • Brug af en stabil vedligeholdelsesdosis af oral Asacol på 1,6 g/dag op til 2,4 g/dag (stabil dosis er defineret som den samme dosis i de sidste 3 måneder)
  • Kvinder skal være postmenopausale eller kirurgisk sterile eller have en negativ uringraviditetstest og anvende acceptabel prævention

Ekskluderingskriterier:

  • Anamnese med eller nuværende nyresygdom
  • Anamnese med leversygdom
  • Anamnese med allergi eller overfølsomhed over for salicylater, aminosalicylater
  • Behandling med immunmodulerende terapi, biologisk terapi eller kortikosteroider inden for 90 dage efter screening
  • Modtaget antidiarré, krampestillende eller antibiotika inden for 1 måned efter screening

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Mesalamin (Asacol) én gang dagligt
en oral, én gang daglig (QD) mesalamin-kur (1,6 - 2,4 g/dag)
Mesalamin tabletter, 1,6-2,4 g/dag indtaget oralt én gang dagligt i 52 uger
Andre navne:
  • Asacol QD
Aktiv komparator: Mesalamin (Asacol) to gange dagligt
en oral, to gange daglig (BID) mesalamin-kur (1,6 - 2,4 g/dag)
Mesalamin tabletter, 1,6-2,4 g/dag, taget to gange dagligt i 52 uger
Andre navne:
  • Asacol BID

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af patienter, der forbliver i remission ved 6. måned, ITT-population, bestemt af Simple Clinical Colitis Activity Index (SCCAI)
Tidsramme: 6 måneder
Remission defineret som SCCAI <5. Simple Clinical Colitis Activity Index: minimumscore 0, maksimumscore 19, afspejler sygdomsaktivitet over de 24 timer før afslutning. Sammensat score: tarmfrekvens (dag, 0-3) (nat, 0-2), hastende afføring (0-3), blod i afføringen (0-3), generel velvære (0-4), ekstrakoloniske træk (gigt , pyoderma gangrenosum, erythema nodosum, uveitis - 1 pr. manifestation).
6 måneder

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af patienter, der forbliver i remission ved 3. måned, ITT-population
Tidsramme: 3 måneder
Remission defineret som SCCAI < 5. Simple Clinical Colitis Activity Index: minimumscore 0, maksimumscore 19, afspejler sygdomsaktivitet over de 24 timer før afslutning. Sammensat score: tarmfrekvens (dag, 0-3) (nat, 0-2), hastende afføring (0-3), blod i afføringen (0-3), generel velvære (0-4), ekstrakoloniske træk (gigt , pyoderma gangrenosum, erythema nodosum, uveitis - 1 pr. manifestation).
3 måneder
Procentdel af patienter, der forbliver i remission ved 12. måned, ITT-population
Tidsramme: 12 måneder
Remission defineret som SCCAI-score < 5. Simple Clinical Colitis Activity Index: minimumscore 0, maksimumscore 19, afspejler sygdomsaktivitet over de 24 timer før afslutning. Sammensat score: tarmfrekvens (dag, 0-3) (nat, 0-2), hastende afføring (0-3), blod i afføringen (0-3), generel velvære (0-4), ekstrakoloniske træk (gigt , pyoderma gangrenosum, erythema nodosum, uveitis - 1 pr. manifestation).
12 måneder
Antal forsøgspersoner, der får tilbagefald/opblussen inden for 6 måneder, ITT-population
Tidsramme: 6 måneder
Tilbagefald/opblussen er defineret som SCCAI >= 5. Simple Clinical Colitis Activity Index: minimumscore 0, maksimumscore 19, afspejler sygdomsaktivitet over de 24 timer før afslutning. Sammensat score: tarmfrekvens (dag, 0-3) (nat, 0-2), hastende afføring (0-3), blod i afføringen (0-3), generel velvære (0-4), ekstrakoloniske træk (gigt , pyoderma gangrenosum, erythema nodosum, uveitis - 1 pr. manifestation).
6 måneder
Total MARS (Medication Adherence Report Scale) Spørgeskemaresultater, ITT-population, måned 6
Tidsramme: 6 måneder
MARS: Sammensat score for følgende udsagn: Jeg ændrer, hvor mange gange om dagen jeg tager min medicin, jeg glemmer at bruge den, jeg stopper med at tage den i et stykke tid, jeg bruger den kun, når jeg har aktive symptomer, jeg beslutter mig for at gå glip af ud på en dosis, jeg tager mindre end anvist, jeg tager mere end anvist, jeg undgår at bruge den, hvis jeg kan, jeg bruger den regelmæssigt hver dag (omvendt score): 5-aldrig, 4-sjældent, 3-nogle gange, 2- ofte, 1-meget ofte. Minimumscore 9, maksimumscore 45.
6 måneder
Procentdel af deltagere, der indikerer colitis ulcerosa i remission (patientdefineret remissionsindeks), ITT-population, måned 6
Tidsramme: 6 måneder
Er din colitis ulcerosa i remission (ikke aktiv)? J/N
6 måneder

Samarbejdspartnere og efterforskere

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

Sponsor

Efterforskere

  • Studieleder: Tom G Todaro, MD, Procter and Gamble

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.

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. juli 2007

Primær færdiggørelse (Faktiske)

1. juli 2009

Studieafslutning (Faktiske)

1. juli 2009

Datoer for studieregistrering

Først indsendt

20. juli 2007

Først indsendt, der opfyldte QC-kriterier

20. juli 2007

Først opslået (Skøn)

23. juli 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. april 2013

Sidst verificeret

1. april 2013

Mere information

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 .

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