A Double Blind Study for the Treatment of Acute Ulcerative Colitis
NCT ID: NCT00350415
Last Updated: 2013-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
772 participants
INTERVENTIONAL
2006-06-30
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Asacol 2.4 g/day (400 mg tablet)
Mesalamine
Asacol 400g/day (400 mg tablet), oral, for 6 weeks
OR
Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
2
Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks
Mesalamine
Asacol 400g/day (400 mg tablet), oral, for 6 weeks
OR
Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
Interventions
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Mesalamine
Asacol 400g/day (400 mg tablet), oral, for 6 weeks
OR
Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Female patients need to be postmenopausal or using adequate contraception.
Exclusion Criteria
* Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.
18 Years
75 Years
ALL
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Piotr Krzeski, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Research Facility
Alabaster, Alabama, United States
Research Facility
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Fayetteville, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Burbank, California, United States
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Encinitas, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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San Carlos, California, United States
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San Francisco, California, United States
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Lakewood, Colorado, United States
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Littleton, Colorado, United States
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Hamden, Connecticut, United States
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DeLand, Florida, United States
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Harbor Village, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Panama City, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Savannah, Georgia, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Chevy Chase, Maryland, United States
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Reisterstown, Maryland, United States
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Boston, Massachusetts, United States
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Columbia, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Scottsbluff, Nebraska, United States
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Egg Harbor, New Jersey, United States
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Binghamton, New York, United States
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Garden City, New York, United States
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Great Neck, New York, United States
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Huntington, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Troy, New York, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Bismarck, North Dakota, United States
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Fargo, North Dakota, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Warren, Ohio, United States
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Portland, Oregon, United States
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Beaver Falls, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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York, Pennsylvania, United States
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Columbia, South Carolina, United States
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Kingsport, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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San Antonio, Texas, United States
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Murray, Utah, United States
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Ogden, Utah, United States
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Burlington, Vermont, United States
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Chesapeake, Virginia, United States
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Redmond, Washington, United States
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Milwaukee, Wisconsin, United States
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Gornel, Gormel, Belarus
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Hrodna, Grodnenskaya, Belarus
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Minsk, Minsk City, Belarus
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Vitebsk, Vitebsk Oblast, Belarus
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Edmonton, Alberta, Canada
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Abbotsford, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Guelph, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Lévis, Quebec, Canada
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Longheuil, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Rimouski, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Zagreb, City of Zagreb, Croatia
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Rijeka, Rijeka, Croatia
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Kralove, Kralove, Czechia
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Pavlov, Pavlov, Czechia
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Prague, Praha 2, Czechia
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Strakonice, Strakonice, Czechia
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Ústí nad Labem, Usti nad Labem, Czechia
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Tallinn, Tallinn, Estonia
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Tartu, Tartu, Estonia
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Argenti Dome Ter, Argenti Dome Ter, Hungary
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Budapest, Budapest, Hungary
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Nagyerdei Krt, Nagyerdei Krt, Hungary
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Riga, Rīga, Latvia
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Kaunas, Kaunas County, Lithuania
Research FacilityPanevezys
Panevezys, Panevėžys, Lithuania
Research Facility
Santariskiu, Vilnius County, Lithuania
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Bydgoszcz, Bydgoszcz, Poland
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Częstochowa, Czestochowa, Poland
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Krakow, Krakow, Poland
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Pruszków, Pruszkow, Poland
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Sopot, Sopot, Poland
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Warsaw, Warszawa, Poland
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Wtoctawek, Wtoctawek, Poland
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Lodz, Łódź Voivodeship, Poland
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San Juan, , Puerto Rico
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Bucharest, București, Romania
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Cluj-Napoca, Cluj-napoca, Romania
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Iași, Iaşi, Romania
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Moscow, Mowcow, Russia
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Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Research Facility
Saint Petersburg, Sankt-Peterburg, Russia
Research Facility
Belgrade, Beograd, Serbia
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Novi Sad, Novi Sad, Serbia
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Kharkiv, Kharkivs’ka Oblast’, Ukraine
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Kyiv, Kyiv Oblast, Ukraine
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Zabolotnogo, Odesa Oblast, Ukraine
Research Facility
Simpheropol, Simpheropol, Ukraine
Research Facility
Zaporizhzhya, Zaporizhzhya, Ukraine
Countries
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Related Links
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Related Info
Other Identifiers
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2006444
Identifier Type: -
Identifier Source: org_study_id
NCT00336440
Identifier Type: -
Identifier Source: nct_alias
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