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A Double Blind Study for the Treatment of Acute Ulcerative Colitis

15. april 2013 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

772

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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 føderasjonen
      • Nizhny Novgorod, Den russiske føderasjonen, 603126
        • Research Facility
      • St. Petersburg, Den russiske føderasjonen, 196247
        • Research Facility
    • Mowcow
      • Moscow, Mowcow, Den russiske føderasjonen, 129110
        • Research Facility
  • Estland
      • Tallinn, Estland, 10138
        • Research Facility
      • Tartu, Estland, 51014
        • Research Facility
  • Forente stater
    • Alabama
      • Alabaster, Alabama, Forente stater, 35007
        • Research Facility
      • Birmingham, Alabama, Forente stater, 35209
        • Research Facility
    • Arizona
      • Tucson, Arizona, Forente stater, 85712
        • Research Facility
    • Arkansas
      • Fayetteville, Arkansas, Forente stater, 72703
        • Research Facility
      • Little Rock, Arkansas, Forente stater, 72205
        • Research Facility
    • California
      • Anaheim, California, Forente stater, 92801
        • Research Facility
      • Burbank, California, Forente stater, 91505
        • Research Facility
      • Encinitas, California, Forente stater, 93024
        • Research Facility
      • Los Angeles, California, Forente stater, 90067
        • Research Facility
      • Los Angeles, California, Forente stater, 90274
        • Research Facility
      • Mission Hills, California, Forente stater, 91345
        • Research Facility
      • Orange, California, Forente stater, 92868
        • Research Facility
      • Pasadena, California, Forente stater, 91105
        • Research Facility
      • Roseville, California, Forente stater, 95661
        • Research Facility
      • Sacramento, California, Forente stater, 95825
        • Research Facility
      • San Carlos, California, Forente stater, 94070
        • Research Facility
      • San Francisco, California, Forente stater, 94115
        • Research Facility
    • Colorado
      • Lakewood, Colorado, Forente stater, 80215
        • Research Facility
      • Littleton, Colorado, Forente stater, 80120
        • Research Facility
    • Connecticut
      • Hamden, Connecticut, Forente stater, 06518-3691
        • Research Facility
    • Florida
      • Deland, Florida, Forente stater, 32720
        • Research Facility
      • Harbor, Florida, Forente stater, 34684
        • Research Facility
      • Hollywood, Florida, Forente stater, 33021
        • Research Facility
      • Jacksonville, Florida, Forente stater, 32256
        • Research Facility
      • Panama City, Florida, Forente stater, 33405
        • Research Facility
      • Zephyrhills, Florida, Forente stater, 33542
        • Research Facility
    • Georgia
      • Atlanta, Georgia, Forente stater, 30033
        • Research Facility
      • Savannah, Georgia, Forente stater, 31405
        • Research Facility
    • Illinois
      • Arlington Heights, Illinois, Forente stater, 60005
        • Research Facility
      • Chicago, Illinois, Forente stater, 60637
        • Research Facility
    • Kansas
      • Topeka, Kansas, Forente stater, 60606
        • Research Facility
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40292
        • Research Facility
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70809
        • Research Facility
      • Shreveport, Louisiana, Forente stater, 71103
        • Research Facility
    • Maryland
      • Baltimore, Maryland, Forente stater, 21215
        • Research Facility
      • Chevy Chase, Maryland, Forente stater, 20815
        • Research Facility
      • Reisterstown, Maryland, Forente stater, 21136
        • Research Facility
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Research Facility
    • Michigan
      • Columbia, Michigan, Forente stater, 65212
        • Research Facility
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • Research Facility
      • Rochester, Minnesota, Forente stater, 55905
        • Research Facility
    • Mississippi
      • Tupelo, Mississippi, Forente stater, 38801
        • Research Facility
    • Missouri
      • Kansas City, Missouri, Forente stater, 64131
        • Research Facility
      • St. Louis, Missouri, Forente stater, 63128
        • Research Facility
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68131
        • Research Facility
      • Scottsbluff, Nebraska, Forente stater, 69361
        • Research Facility
    • New Jersey
      • Egg Harbor Township, New Jersey, Forente stater, 08234
        • Research Facility
    • New York
      • Binghamton, New York, Forente stater, 13903
        • Research Facility
      • Garden City, New York, Forente stater, 11530
        • Research Facility
      • Great Neck, New York, Forente stater, 11021
        • Research Facility
      • Huntington, New York, Forente stater, 11743
        • Research Facility
      • New York, New York, Forente stater, 10021
        • Research Facility
      • Rochester, New York, Forente stater, 14642
        • Research Facility
      • Troy, New York, Forente stater, 12180
        • Research Facility
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28262
        • Research Facility
      • Wilmington, North Carolina, Forente stater, 28401
        • Research Facility
    • North Dakota
      • Bismarck, North Dakota, Forente stater, 58501-1640
        • Research Facility
      • Fargo, North Dakota, Forente stater, 58104
        • Research Facility
    • Ohio
      • Akron, Ohio, Forente stater, 44302
        • Research Facility
      • Cincinnati, Ohio, Forente stater, 45242
        • Research Facility
      • Dayton, Ohio, Forente stater, 45440
        • Research Facility
      • Warren, Ohio, Forente stater, 44484
        • Research Facility
    • Oregon
      • Portland, Oregon, Forente stater, 97220
        • Research Facility
    • Pennsylvania
      • Beaver Falls, Pennsylvania, Forente stater, 15010
        • Research Facility
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Research Facility
      • York, Pennsylvania, Forente stater, 17403
        • Research Facility
    • South Carolina
      • Columbia, South Carolina, Forente stater, 29203
        • Research Facility
    • Tennessee
      • Kingsport, Tennessee, Forente stater, 37660
        • Research Facility
      • Memphis, Tennessee, Forente stater, 38120
        • Research Facility
      • Nashville, Tennessee, Forente stater, 37232
        • Research Facility
    • Texas
      • Austin, Texas, Forente stater, 78743
        • Research Facility
      • San Antonio, Texas, Forente stater, 78205
        • Research Facility
    • Utah
      • Murray, Utah, Forente stater, 84107
        • Research Facility
      • Ogden, Utah, Forente stater, 84405
        • Research Facility
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • Research Facility
    • Virginia
      • Chesapeake, Virginia, Forente stater, 23320
        • Research Facility
    • Washington
      • Redmond, Washington, Forente stater, 98052
        • Research Facility
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Research Facility
  • Hviterussland
      • Grodno, Hviterussland, 230017
        • Research Facility
      • Minsk, Hviterussland, 220013
        • Research Facility
      • Vitebsk, Hviterussland, 210037
        • Research Facility
    • Gormel
      • Gornel, Gormel, Hviterussland
        • Research Facility
  • Kroatia
      • Rijeka, Kroatia, 51000
        • Research Facility
      • Zagreb, Kroatia, 10000
        • Research Facility
  • Latvia
      • Riga, Latvia, 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
  • Romania
      • Cluj-napoca, Romania, 400162
        • Research Facility
      • Iasi, Romania, 700111
        • Research Facility
    • Bucuresti
      • Bucuresti 1, Bucuresti, Romania, 010825
        • Research Facility
  • Serbia
      • Beograd, Serbia, 11080
        • Research Facility
      • Novi Sad, Serbia, 21000
        • Research Facility
  • Tsjekkisk Republikk
      • Kralove, Tsjekkisk Republikk, 500 12
        • Research Facility
      • Pavlov, Tsjekkisk Republikk
        • Research Facility
      • Praha 2, Tsjekkisk Republikk, 120 00
        • Research Facility
      • Strakonice, Tsjekkisk Republikk, 3886 29
        • Research Facility
      • Usti nad Labem, Tsjekkisk Republikk, 401 13
        • Research Facility
  • Ukraina
      • Kharkiv, Ukraina, 61037
        • Research Facility
      • Kyiv, Ukraina, 04053
        • Research Facility
      • Simpheropol, Ukraina, 95000
        • Research Facility
      • Zaporizhzhya, Ukraina, 69050
        • Research Facility
    • Odesa
      • Zabolotnogo, Odesa, Ukraina, 65025
        • Research Facility
  • Ungarn
      • Argenti Dome ter, Ungarn, 1-3
        • Research Facility
      • Budapest, Ungarn
        • Research Facility
      • Nagyerdei krt, Ungarn, 98
        • Research Facility

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Asacol 2.4 g/day (400 mg tablet)
Legemiddel: 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
Legemiddel: Mesalamine

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

OR

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

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Warner Chilcott

Etterforskere

  • Studieleder: Piotr Krzeski, MD, Procter and Gamble

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2006

Primær fullføring (Faktiske)

1. mai 2007

Studiet fullført (Faktiske)

1. mai 2007

Datoer for studieregistrering

Først innsendt

6. juli 2006

Først innsendt som oppfylte QC-kriteriene

6. juli 2006

Først lagt ut (Anslag)

10. juli 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. april 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. april 2013

Sist bekreftet

1. april 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2006444

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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