A Comparison of Once a Day Dose Compared to 2 Doses/Day
NCT ID: NCT00505778
Last Updated: 2013-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1027 participants
INTERVENTIONAL
2007-07-31
2009-07-31
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
SINGLE
Study Groups
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Mesalamine (Asacol) Once-Daily
an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
Mesalamine Once-Daily
Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
Mesalamine (Asacol) Twice-Daily
an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Mesalamine Twice-Daily
Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks
Interventions
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Mesalamine Once-Daily
Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
Mesalamine Twice-Daily
Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one flare in the past 18 months
* Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months)
* Females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception
Exclusion Criteria
* History of hepatic disease
* History of allergy or hypersensitivity to salicylates, aminosalicylates
* Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening
* Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening
18 Years
ALL
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Tom G Todaro, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Athens, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Tuscon, Arizona, United States
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Little Rock, Arkansas, United States
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Lowell, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Chico, California, United States
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Encinitas, California, United States
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Folsom, California, United States
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La Mesa, California, United States
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Lancaster, California, United States
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Long Beach, 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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Madera, California, United States
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Merced, California, United States
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Mission Hills, California, United States
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Monterey, California, United States
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Murrieta, California, United States
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Oakland, California, United States
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Orange, California, United States
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Palm Springs, California, United States
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San Carlos, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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Torrance, California, United States
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Torrance, California, United States
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Upland, California, United States
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Englewood, Colorado, United States
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Golden, Colorado, United States
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Lafayette, Colorado, United States
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Pueblo, Colorado, United States
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Hartford, Connecticut, United States
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Meriden, Connecticut, United States
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New Haven, Connecticut, United States
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Norwalk, Connecticut, United States
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Torrington, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Maitland, Florida, United States
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Naples, Florida, United States
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New Port Richey, Florida, United States
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North Miami Beach, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Port Orange, Florida, United States
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St. Petersburg, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Trinity, Florida, United States
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Winter Park, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Marietta, Georgia, United States
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Newnan, Georgia, United States
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Savannah, Georgia, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Arlington Heights, Illinois, United States
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Berwyn, Illinois, United States
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Chicago, Illinois, United States
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Elgin, Illinois, United States
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Highland Park, Illinois, United States
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Hoffman Estates, Illinois, United States
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Homewood, Illinois, United States
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Lake Barrington, Illinois, United States
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Oak Lawn, Illinois, United States
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Peoria, Illinois, United States
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Urbana, Illinois, United States
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Anderson, Indiana, United States
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Bloomington, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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South Bend, Indiana, United States
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Clive, Iowa, United States
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Davenport, Iowa, United States
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Waterloo, Iowa, United States
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Pratt, Kansas, United States
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Topeka, Kansas, United States
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Whichita, Kansas, United States
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Bowling Green, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Alexandria, Louisiana, United States
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Lafayette, Louisiana, United States
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Metairie, Louisiana, United States
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Monroe, Louisiana, United States
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Shreveport, Louisiana, United States
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Bangor, Maine, United States
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Chevy Chase, Maryland, United States
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College Park, Maryland, United States
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Greenbelt, Maryland, United States
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Hagerstown, Maryland, United States
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Hollywood, Maryland, United States
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Lutherville, Maryland, United States
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Reisterstown, Maryland, United States
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Rockville, Maryland, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Braintree, Massachusetts, United States
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Southbridge, Massachusetts, United States
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Chesterfield, Michigan, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Troy, Michigan, United States
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West Bloomfied, Michigan, United States
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Wyoming, Michigan, United States
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Rochester, Minnesota, United States
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Tupelo, Mississippi, United States
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Cape Girardeau, Missouri, United States
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Columbia, Missouri, United States
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Jefferson City, Missouri, United States
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Mexico, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Somersworth, New Hampshire, United States
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Camden, New Jersey, United States
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Cedar Knolls, New Jersey, United States
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Egg Harbor, New Jersey, United States
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Hackensack, New Jersey, United States
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Ocean City, New Jersey, United States
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South Plainfield, New Jersey, United States
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Albuquerque, New Mexico, United States
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Babylon, New York, United States
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Binghamton, New York, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Cheektowaga, New York, United States
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Cortland, New York, United States
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Forest Hills, 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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Great Neck, New York, United States
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Lake Success, New York, United States
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New York, New York, United States
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New York, New York, United States
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Pittsford, New York, United States
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Port Jefferson Station, New York, United States
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Rochester, New York, United States
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Rochester, New York, United States
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Boone, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Jacksonville, North Carolina, United States
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Kinston, North Carolina, United States
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Morganton, North Carolina, United States
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Mount Airy, North Carolina, United States
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New Bern, North Carolina, United States
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Pinehurst, North Carolina, United States
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Raleigh, 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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Akron, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Mentor, Ohio, United States
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Toledo, Ohio, United States
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Westlake, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Beaver Falls, Pennsylvania, United States
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Clairton, Pennsylvania, United States
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Indiana, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sewickley, Pennsylvania, United States
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Souderton, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Columbia, South Carolina, United States
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Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Jackson, Tennessee, United States
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Jackson, Tennessee, United States
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Memphis, Tennessee, United States
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Morristown, Tennessee, United States
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Amarillo, Texas, United States
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Fort Worth, Texas, United States
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Greenville, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lewisville, Texas, United States
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Longview, Texas, United States
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Odessa, Texas, United States
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Pasadena, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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West Valley City, Utah, United States
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Alexandria, Virginia, United States
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Chesapeake, Virginia, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Winchester, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wenatchee, Washington, United States
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Milwaukee, Wisconsin, United States
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Monroe, Wisconsin, United States
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Abbotsford, British Columbia, Canada
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Guelph, Ontario, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, 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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Ponce, , Puerto Rico
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San Juan, , Puerto Rico
Countries
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References
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Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, Safdi M, Sninsky CA, Patel RM, Friedenberg KA, Dunnmon P, Ramsey D, Kane S. Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. Gastroenterology. 2010 Apr;138(4):1286-96, 1296.e1-3. doi: 10.1053/j.gastro.2009.12.054. Epub 2010 Jan 11.
Other Identifiers
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2007021
Identifier Type: -
Identifier Source: org_study_id
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