A Double Blind Study for the Treatment of Acute Ulcerative Colitis

NCT00350415 | Completed Phase 3

• 1 other identifier: 2006444
• Study Type: interventional
• Target: 772
• Locations: 15 countries
• Sites: 135

Brief Summary

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).

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis, inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

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

  Week 6

Secondary Outcomes (1)

• 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.

  week 3 and 6

Study Arms (2)

1

EXPERIMENTAL

Asacol 2.4 g/day (400 mg tablet)

Drug: Mesalamine

2

ACTIVE COMPARATOR

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

Drug: Mesalamine

Interventions

Mesalamine DRUG

Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (135)

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Alabaster, Alabama, 35007, United States

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Birmingham, Alabama, 35209, United States

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Tucson, Arizona, 85712, United States

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Fayetteville, Arkansas, 72703, United States

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Little Rock, Arkansas, 72205, United States

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Anaheim, California, 92801, United States

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Burbank, California, 91505, United States

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Encinitas, California, 93024, United States

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Los Angeles, California, 90067, United States

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Los Angeles, California, 90274, United States

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Mission Hills, California, 91345, United States

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Orange, California, 92868, United States

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Pasadena, California, 91105, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95825, United States

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San Carlos, California, 94070, United States

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San Francisco, California, 94115, United States

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Lakewood, Colorado, 80215, United States

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Littleton, Colorado, 80120, United States

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Hamden, Connecticut, 06518-3691, United States

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DeLand, Florida, 32720, United States

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Harbor Village, Florida, 34684, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32256, United States

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Panama City, Florida, 33405, United States

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Zephyrhills, Florida, 33542, United States

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Atlanta, Georgia, 30033, United States

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Savannah, Georgia, 31405, United States

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Arlington Heights, Illinois, 60005, United States

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Chicago, Illinois, 60637, United States

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Topeka, Kansas, 60606, United States

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Louisville, Kentucky, 40292, United States

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Baton Rouge, Louisiana, 70809, United States

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Shreveport, Louisiana, 71103, United States

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Baltimore, Maryland, 21215, United States

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Chevy Chase, Maryland, 20815, United States

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Reisterstown, Maryland, 21136, United States

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Boston, Massachusetts, 02115, United States

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Columbia, Michigan, 65212, United States

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Minneapolis, Minnesota, 55455, United States

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Rochester, Minnesota, 55905, United States

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Tupelo, Mississippi, 38801, United States

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Kansas City, Missouri, 64131, United States

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St Louis, Missouri, 63128, United States

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Omaha, Nebraska, 68131, United States

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Scottsbluff, Nebraska, 69361, United States

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Egg Harbor, New Jersey, 08234, United States

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Binghamton, New York, 13903, United States

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Garden City, New York, 11530, United States

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Great Neck, New York, 11021, United States

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Huntington, New York, 11743, United States

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New York, New York, 10021, United States

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Rochester, New York, 14642, United States

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Troy, New York, 12180, United States

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Charlotte, North Carolina, 28262, United States

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Wilmington, North Carolina, 28401, United States

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Bismarck, North Dakota, 58501-1640, United States

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Fargo, North Dakota, 58104, United States

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Akron, Ohio, 44302, United States

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Cincinnati, Ohio, 45242, United States

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Dayton, Ohio, 45440, United States

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Warren, Ohio, 44484, United States

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Portland, Oregon, 97220, United States

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Beaver Falls, Pennsylvania, 15010, United States

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Philadelphia, Pennsylvania, 19107, United States

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York, Pennsylvania, 17403, United States

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Columbia, South Carolina, 29203, United States

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Kingsport, Tennessee, 37660, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37232, United States

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Austin, Texas, 78743, United States

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San Antonio, Texas, 78205, United States

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Murray, Utah, 84107, United States

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Ogden, Utah, 84405, United States

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Burlington, Vermont, 05401, United States

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Chesapeake, Virginia, 23320, United States

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Redmond, Washington, 98052, United States

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Milwaukee, Wisconsin, 53215, United States

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Gornel, Gormel, Belarus

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Hrodna, Grodnenskaya, 230017, Belarus

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Minsk, Minsk City, 220013, Belarus

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Vitebsk, Vitebsk Oblast, 210037, Belarus

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Edmonton, Alberta, T6G 2X8, Canada

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Abbotsford, British Columbia, V2S 3N5, Canada

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Vancouver, British Columbia, V5Z 112, Canada

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Guelph, Ontario, N1H 3R3, Canada

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Hamilton, Ontario, L8N 3Z5, Canada

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London, Ontario, N6A 5K8, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M3N 2V7, Canada

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Lévis, Quebec, G6V 3Z1, Canada

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Longheuil, Quebec, J4N 1E1, Canada

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Montreal, Quebec, H31 1E2, Canada

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Québec, Quebec, G1L 3L5, Canada

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Québec, Quebec, G1R 2J6, Canada

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Rimouski, Quebec, G5L 5T1, Canada

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Saskatoon, Saskatchewan, S7K 1N4, Canada

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Zagreb, City of Zagreb, 10000, Croatia

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Rijeka, Rijeka, 51000, Croatia

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Kralove, Kralove, 500 12, Czechia

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Pavlov, Pavlov, Czechia

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Prague, Praha 2, 120 00, Czechia

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Strakonice, Strakonice, 3886 29, Czechia

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Ústí nad Labem, Usti nad Labem, 401 13, Czechia

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Tallinn, Tallinn, 10138, Estonia

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Tartu, Tartu, 51014, Estonia

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Argenti Dome Ter, Argenti Dome Ter, 1-3, Hungary

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Budapest, Budapest, Hungary

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Nagyerdei Krt, Nagyerdei Krt, 98, Hungary

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Riga, Rīga, LV-1002, Latvia

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Kaunas, Kaunas County, LT-50009, Lithuania

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Research FacilityPanevezys

Panevezys, Panevėžys, LT-35144, Lithuania

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Santariskiu, Vilnius County, LT-08661, Lithuania

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Bydgoszcz, Bydgoszcz, 85-681, Poland

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Częstochowa, Czestochowa, 42-200, Poland

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Krakow, Krakow, 31-501, Poland

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Pruszków, Pruszkow, 05-800, Poland

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Sopot, Sopot, 81-756, Poland

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Warsaw, Warszawa, 02-57, Poland

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Wtoctawek, Wtoctawek, 87-800, Poland

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Lodz, Łódź Voivodeship, 90-153, Poland

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San Juan, 5067, Puerto Rico

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Bucharest, București, 010825, Romania

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Cluj-Napoca, Cluj-napoca, 400162, Romania

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Iași, Iaşi, 700111, Romania

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Moscow, Mowcow, 129110, Russia

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Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia

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Saint Petersburg, Sankt-Peterburg, 196247, Russia

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Belgrade, Beograd, 11080, Serbia

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Novi Sad, Novi Sad, 21000, Serbia

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Kharkiv, Kharkivs’ka Oblast’, 61037, Ukraine

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Kyiv, Kyiv Oblast, 04053, Ukraine

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Zabolotnogo, Odesa Oblast, 65025, Ukraine

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Simpheropol, Simpheropol, 95000, Ukraine

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Zaporizhzhya, Zaporizhzhya, 69050, Ukraine

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Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Piotr Krzeski, MD

  Procter and Gamble

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2006
• First Posted: July 10, 2006
• Study Start: June 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

LA (1); LI (3); RU (3); BE (4); UA (5); HU (3); US (78); PL (8); CR (2); CA (15); ES (2); RO (3); PR (1); CZ (5); SE (2)