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

A Double Blind Study for the Treatment of Acute Ulcerative Colitis

15. april 2013 opdateret af: Warner Chilcott

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

772

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
      • Quebec, Canada, G1L 3L5
        • Research Facility
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • Research Facility
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
        • Research Facility
      • Vancouver, British Columbia, Canada, V5Z 112
        • Research Facility
    • Ontario
      • Guelph, Ontario, Canada, N1H 3R3
        • Research Facility
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Research Facility
      • London, Ontario, Canada, N6A 5K8
        • Research Facility
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Facility
      • Toronto, Ontario, Canada, M3N 2V7
        • Research Facility
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • Research Facility
      • Longheuil, Quebec, Canada, J4N 1E1
        • Research Facility
      • Montreal, Quebec, Canada, H31 1E2
        • Research Facility
      • Quebec City, Quebec, Canada, G1R 2J6
        • Research Facility
      • Rimouski, Quebec, Canada, G5L 5T1
        • Research Facility
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1N4
        • Research Facility
  • Den Russiske Føderation
      • Nizhny Novgorod, Den Russiske Føderation, 603126
        • Research Facility
      • St. Petersburg, Den Russiske Føderation, 196247
        • Research Facility
    • Mowcow
      • Moscow, Mowcow, Den Russiske Føderation, 129110
        • Research Facility
  • Estland
      • Tallinn, Estland, 10138
        • Research Facility
      • Tartu, Estland, 51014
        • Research Facility
  • Forenede Stater
    • Alabama
      • Alabaster, Alabama, Forenede Stater, 35007
        • Research Facility
      • Birmingham, Alabama, Forenede Stater, 35209
        • Research Facility
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85712
        • Research Facility
    • Arkansas
      • Fayetteville, Arkansas, Forenede Stater, 72703
        • Research Facility
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Research Facility
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Research Facility
      • Burbank, California, Forenede Stater, 91505
        • Research Facility
      • Encinitas, California, Forenede Stater, 93024
        • Research Facility
      • Los Angeles, California, Forenede Stater, 90067
        • Research Facility
      • Los Angeles, California, Forenede Stater, 90274
        • Research Facility
      • Mission Hills, California, Forenede Stater, 91345
        • Research Facility
      • Orange, California, Forenede Stater, 92868
        • Research Facility
      • Pasadena, California, Forenede Stater, 91105
        • Research Facility
      • Roseville, California, Forenede Stater, 95661
        • Research Facility
      • Sacramento, California, Forenede Stater, 95825
        • Research Facility
      • San Carlos, California, Forenede Stater, 94070
        • Research Facility
      • San Francisco, California, Forenede Stater, 94115
        • Research Facility
    • Colorado
      • Lakewood, Colorado, Forenede Stater, 80215
        • Research Facility
      • Littleton, Colorado, Forenede Stater, 80120
        • Research Facility
    • Connecticut
      • Hamden, Connecticut, Forenede Stater, 06518-3691
        • Research Facility
    • Florida
      • Deland, Florida, Forenede Stater, 32720
        • Research Facility
      • Harbor, Florida, Forenede Stater, 34684
        • Research Facility
      • Hollywood, Florida, Forenede Stater, 33021
        • Research Facility
      • Jacksonville, Florida, Forenede Stater, 32256
        • Research Facility
      • Panama City, Florida, Forenede Stater, 33405
        • Research Facility
      • Zephyrhills, Florida, Forenede Stater, 33542
        • Research Facility
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30033
        • Research Facility
      • Savannah, Georgia, Forenede Stater, 31405
        • Research Facility
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60005
        • Research Facility
      • Chicago, Illinois, Forenede Stater, 60637
        • Research Facility
    • Kansas
      • Topeka, Kansas, Forenede Stater, 60606
        • Research Facility
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40292
        • Research Facility
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Research Facility
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Research Facility
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21215
        • Research Facility
      • Chevy Chase, Maryland, Forenede Stater, 20815
        • Research Facility
      • Reisterstown, Maryland, Forenede Stater, 21136
        • Research Facility
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Research Facility
    • Michigan
      • Columbia, Michigan, Forenede Stater, 65212
        • Research Facility
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Research Facility
      • Rochester, Minnesota, Forenede Stater, 55905
        • Research Facility
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Research Facility
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64131
        • Research Facility
      • St. Louis, Missouri, Forenede Stater, 63128
        • Research Facility
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68131
        • Research Facility
      • Scottsbluff, Nebraska, Forenede Stater, 69361
        • Research Facility
    • New Jersey
      • Egg Harbor Township, New Jersey, Forenede Stater, 08234
        • Research Facility
    • New York
      • Binghamton, New York, Forenede Stater, 13903
        • Research Facility
      • Garden City, New York, Forenede Stater, 11530
        • Research Facility
      • Great Neck, New York, Forenede Stater, 11021
        • Research Facility
      • Huntington, New York, Forenede Stater, 11743
        • Research Facility
      • New York, New York, Forenede Stater, 10021
        • Research Facility
      • Rochester, New York, Forenede Stater, 14642
        • Research Facility
      • Troy, New York, Forenede Stater, 12180
        • Research Facility
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28262
        • Research Facility
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Research Facility
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501-1640
        • Research Facility
      • Fargo, North Dakota, Forenede Stater, 58104
        • Research Facility
    • Ohio
      • Akron, Ohio, Forenede Stater, 44302
        • Research Facility
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Research Facility
      • Dayton, Ohio, Forenede Stater, 45440
        • Research Facility
      • Warren, Ohio, Forenede Stater, 44484
        • Research Facility
    • Oregon
      • Portland, Oregon, Forenede Stater, 97220
        • Research Facility
    • Pennsylvania
      • Beaver Falls, Pennsylvania, Forenede Stater, 15010
        • Research Facility
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Research Facility
      • York, Pennsylvania, Forenede Stater, 17403
        • Research Facility
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Research Facility
    • Tennessee
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Research Facility
      • Memphis, Tennessee, Forenede Stater, 38120
        • Research Facility
      • Nashville, Tennessee, Forenede Stater, 37232
        • Research Facility
    • Texas
      • Austin, Texas, Forenede Stater, 78743
        • Research Facility
      • San Antonio, Texas, Forenede Stater, 78205
        • Research Facility
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Research Facility
      • Ogden, Utah, Forenede Stater, 84405
        • Research Facility
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Research Facility
    • Virginia
      • Chesapeake, Virginia, Forenede Stater, 23320
        • Research Facility
    • Washington
      • Redmond, Washington, Forenede Stater, 98052
        • Research Facility
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Research Facility
  • Hviderusland
      • Grodno, Hviderusland, 230017
        • Research Facility
      • Minsk, Hviderusland, 220013
        • Research Facility
      • Vitebsk, Hviderusland, 210037
        • Research Facility
    • Gormel
      • Gornel, Gormel, Hviderusland
        • Research Facility
  • Kroatien
      • Rijeka, Kroatien, 51000
        • Research Facility
      • Zagreb, Kroatien, 10000
        • Research Facility
  • Letland
      • Riga, Letland, LV-1002
        • Research Facility
  • Litauen
      • Kaunas, Litauen, LT-50009
        • Research Facility
      • Panevezys, Litauen, LT-35144
        • Research FacilityPanevezys
    • Vilnius
      • Santariskiu, Vilnius, Litauen, LT-08661
        • Research Facility
  • Polen
      • Bydgoszcz, Polen, 85-681
        • Research Facility
      • Czestochowa, Polen, 42-200
        • Research Facility
      • Krakow, Polen, 31-501
        • Research Facility
      • Lodz, Polen, 90-153
        • Research Facility
      • Pruszkow, Polen, 05-800
        • Research Facility
      • Sopot, Polen, 81-756
        • Research Facility
      • Warszawa, Polen, 02-57
        • Research Facility
      • Wtoctawek, Polen, 87-800
        • Research Facility
  • Puerto Rico
      • San Juan, Puerto Rico, 5067
        • Research Facility
  • Rumænien
      • Cluj-napoca, Rumænien, 400162
        • Research Facility
      • Iasi, Rumænien, 700111
        • Research Facility
    • Bucuresti
      • Bucuresti 1, Bucuresti, Rumænien, 010825
        • Research Facility
  • Serbien
      • Beograd, Serbien, 11080
        • Research Facility
      • Novi Sad, Serbien, 21000
        • Research Facility
  • Tjekkiet
      • Kralove, Tjekkiet, 500 12
        • Research Facility
      • Pavlov, Tjekkiet
        • Research Facility
      • Praha 2, Tjekkiet, 120 00
        • Research Facility
      • Strakonice, Tjekkiet, 3886 29
        • Research Facility
      • Usti nad Labem, Tjekkiet, 401 13
        • Research Facility
  • Ukraine
      • Kharkiv, Ukraine, 61037
        • Research Facility
      • Kyiv, Ukraine, 04053
        • Research Facility
      • Simpheropol, Ukraine, 95000
        • Research Facility
      • Zaporizhzhya, Ukraine, 69050
        • Research Facility
    • Odesa
      • Zabolotnogo, Odesa, Ukraine, 65025
        • Research Facility
  • Ungarn
      • Argenti Dome ter, Ungarn, 1-3
        • Research Facility
      • Budapest, Ungarn
        • Research Facility
      • Nagyerdei krt, Ungarn, 98
        • 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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
  • Female patients need to be postmenopausal or using adequate contraception.

Exclusion Criteria:

  • Patients with isolated proctitis
  • Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.

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: 1
Asacol 2.4 g/day (400 mg tablet)
Medicin: Mesalamine

Asacol 400g/day (400 mg tablet), oral, for 6 weeks

OR

Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
Aktiv komparator: 2
Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks
Medicin: Mesalamine

Asacol 400g/day (400 mg tablet), oral, for 6 weeks

OR

Asacol 4,8 g/day (800 mg table), oral, for 6 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
Tidsramme: Week 6
Week 6

Sekundære resultatmål

Resultatmål
Tidsramme
Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3.
Tidsramme: week 3 and 6
week 3 and 6

Samarbejdspartnere og efterforskere

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

Sponsor

Warner Chilcott

Efterforskere

  • Studieleder: Piotr Krzeski, 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.

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. juni 2006

Primær færdiggørelse (Faktiske)

1. maj 2007

Studieafslutning (Faktiske)

1. maj 2007

Datoer for studieregistrering

Først indsendt

6. juli 2006

Først indsendt, der opfyldte QC-kriterier

6. juli 2006

Først opslået (Skøn)

10. juli 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. april 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2006444

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 Colitis ulcerosa

Kliniske forsøg med Mesalamine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Iran

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner