A Comparison of Once a Day Dose Compared to 2 Doses/Day
A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis
1 other identifier
interventional
1,027
3 countries
245
Brief Summary
The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2007
245 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 20, 2007
CompletedFirst Posted
Study publicly available on registry
July 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
May 12, 2011
CompletedApril 22, 2013
April 1, 2013
2 years
July 20, 2007
April 18, 2011
April 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)
Remission defined as SCCAI \<5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).
6 months
Secondary Outcomes (5)
Percentage of Patients Remaining in Remission at Month 3, ITT Population
3 months
Percentage of Patients Remaining in Remission at Month 12, ITT Population
12 months
Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population
6 months
Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6
6 months
Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6
6 months
Study Arms (2)
Mesalamine (Asacol) Once-Daily
ACTIVE COMPARATORan oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
Mesalamine (Asacol) Twice-Daily
ACTIVE COMPARATORan oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Interventions
Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks
Eligibility Criteria
You may qualify if:
- Documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry
- 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
You may not qualify if:
- History of or current renal disease
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
Study Sites (245)
Research Facility
Athens, Alabama, 35611, United States
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Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35294, United States
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Dothan, Alabama, 26305-1156, United States
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Phoenix, Arizona, 85050, United States
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Scottsdale, Arizona, 85259, United States
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Tucson, Arizona, 85712, United States
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Tuscon, Arizona, 85711, United States
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Little Rock, Arkansas, 72205, United States
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Lowell, Arkansas, 72745, United States
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Anaheim, California, 92801, United States
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Beverly Hills, California, 90210, United States
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Chico, California, 95926, United States
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Encinitas, California, 92024, United States
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Folsom, California, 95630, United States
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La Mesa, California, 91941, United States
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Lancaster, California, 93534, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90015, United States
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Los Angeles, California, 90045, United States
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Madera, California, 93637, United States
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Merced, California, 95340, United States
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Mission Hills, California, 91345, United States
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Monterey, California, 93940, United States
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Murrieta, California, 92562, United States
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Oakland, California, 94609, United States
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Orange, California, 92868, United States
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Palm Springs, California, 92262, United States
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San Carlos, California, 94070, United States
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San Diego, California, 92103, United States
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San Diego, California, 92117, United States
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San Diego, California, 92123, United States
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San Francisco, California, 94117, United States
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San Francisco, California, 94122, United States
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Torrance, California, 90503, United States
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Torrance, California, 90505, United States
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Upland, California, 91786, United States
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Englewood, Colorado, 80113, United States
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Golden, Colorado, 80401, United States
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Lafayette, Colorado, 80026, United States
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Pueblo, Colorado, 81008, United States
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Hartford, Connecticut, 06106, United States
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Meriden, Connecticut, 06451, United States
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New Haven, Connecticut, 06510, United States
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Norwalk, Connecticut, 06851, United States
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Torrington, Connecticut, 06790, United States
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Washington D.C., District of Columbia, 20060, United States
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Aventura, Florida, 33180, United States
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Fort Lauderdale, Florida, 33308, United States
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Gainesville, Florida, 32607, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville, Florida, 32223, United States
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Largo, Florida, 33777, United States
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Maitland, Florida, 32751, United States
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Naples, Florida, 34102, United States
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New Port Richey, Florida, 34652, United States
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North Miami Beach, Florida, 33162, United States
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Orlando, Florida, 32806, United States
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Palm Harbor, Florida, 34684, United States
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Port Orange, Florida, 32129, United States
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St. Petersburg, Florida, 33707, United States
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St. Petersburg, Florida, 33711, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33607, United States
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Tampa, Florida, 33613, United States
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Trinity, Florida, 34655, United States
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Winter Park, Florida, 32789, United States
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Zephyrhills, Florida, 33542, United States
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Atlanta, Georgia, 30342-5000, United States
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Columbus, Georgia, 31904, United States
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Decatur, Georgia, 30033, United States
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Marietta, Georgia, 30060, United States
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Marietta, Georgia, 30067, United States
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Newnan, Georgia, 30263, United States
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Savannah, Georgia, 31406, United States
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Boise, Idaho, 83704, United States
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Idaho Falls, Idaho, 83404, United States
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Arlington Heights, Illinois, 60005, United States
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Berwyn, Illinois, 60402, United States
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Chicago, Illinois, 60637, United States
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Elgin, Illinois, 60123, United States
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Highland Park, Illinois, 60036, United States
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Hoffman Estates, Illinois, 60169, United States
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Homewood, Illinois, 60430, United States
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Lake Barrington, Illinois, 60010, United States
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Oak Lawn, Illinois, 60453, United States
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Peoria, Illinois, 61602, United States
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Urbana, Illinois, 61801, United States
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Anderson, Indiana, 46016, United States
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Bloomington, Indiana, 47403, United States
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Indianapolis, Indiana, 46202, United States
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Indianapolis, Indiana, 46260, United States
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South Bend, Indiana, 46601, United States
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Clive, Iowa, 50325, United States
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Davenport, Iowa, 52807, United States
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Waterloo, Iowa, 50701, United States
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Pratt, Kansas, 67124, United States
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Topeka, Kansas, 66606, United States
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Whichita, Kansas, 67214, United States
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Bowling Green, Kentucky, 42101, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40291, United States
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Alexandria, Louisiana, 71301, United States
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Lafayette, Louisiana, 70503, United States
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Metairie, Louisiana, 70006, United States
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Monroe, Louisiana, 71201, United States
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Shreveport, Louisiana, 71103, United States
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Bangor, Maine, 04401, United States
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Chevy Chase, Maryland, 20815, United States
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College Park, Maryland, 20740, United States
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Greenbelt, Maryland, 20770, United States
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Hagerstown, Maryland, 21740, United States
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Hollywood, Maryland, 20636, United States
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Lutherville, Maryland, 21093, United States
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Reisterstown, Maryland, 21136, United States
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Rockville, Maryland, 20850, United States
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Rockville, Maryland, 20854, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Braintree, Massachusetts, 02184, United States
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Southbridge, Massachusetts, 01550, United States
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Chesterfield, Michigan, 48047, United States
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Detroit, Michigan, 48201, United States
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Kalamazoo, Michigan, 49048, United States
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Troy, Michigan, 48098, United States
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West Bloomfied, Michigan, 48322, United States
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Wyoming, Michigan, 49519, United States
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Rochester, Minnesota, 55905, United States
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Tupelo, Mississippi, 38801, United States
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Cape Girardeau, Missouri, 63703-6364, United States
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Columbia, Missouri, 65212, United States
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Jefferson City, Missouri, 65109, United States
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Mexico, Missouri, 65265, United States
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St Louis, Missouri, 63128, United States
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Las Vegas, Nevada, 89147, United States
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Somersworth, New Hampshire, 03878, United States
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Camden, New Jersey, 08103, United States
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Cedar Knolls, New Jersey, 07927, United States
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Egg Harbor, New Jersey, 08234-5857, United States
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Hackensack, New Jersey, 07601, United States
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Ocean City, New Jersey, 07712, United States
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South Plainfield, New Jersey, 07080, United States
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Albuquerque, New Mexico, 87109, United States
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Babylon, New York, 11702, United States
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Binghamton, New York, 13903, United States
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Brooklyn, New York, 11215, United States
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Brooklyn, New York, 11234, United States
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Cheektowaga, New York, 14225, United States
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Cortland, New York, 13045, United States
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Forest Hills, New York, 10128, 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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Great Neck, New York, 11023, United States
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Lake Success, New York, 11042, United States
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New York, New York, 10016, United States
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New York, New York, 10028, United States
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Pittsford, New York, 14534, United States
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Port Jefferson Station, New York, 11776, United States
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Rochester, New York, 14621, United States
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Rochester, New York, 14625, United States
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Boone, North Carolina, 28607, United States
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Charlotte, North Carolina, 28204, United States
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Greensboro, North Carolina, 27403, United States
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Greenville, North Carolina, 27834, United States
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Jacksonville, North Carolina, 28546, United States
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Kinston, North Carolina, 28501, United States
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Morganton, North Carolina, 28655, United States
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Mount Airy, North Carolina, 27030, United States
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New Bern, North Carolina, 28562, United States
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Pinehurst, North Carolina, 28374, United States
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Raleigh, North Carolina, 27607, United States
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Wilmington, North Carolina, 28401, United States
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Bismarck, North Dakota, 58501, United States
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Akron, Ohio, 44302, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45242, United States
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Cleveland, Ohio, 44195, United States
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Dayton, Ohio, 45415, United States
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Dayton, Ohio, 45440, United States
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Mentor, Ohio, 44060, United States
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Toledo, Ohio, 43617, United States
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Westlake, Ohio, 44145, United States
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Tulsa, Oklahoma, 74104, United States
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Portland, Oregon, 97225, United States
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Allentown, Pennsylvania, 18104, United States
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Beaver Falls, Pennsylvania, 15010, United States
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Clairton, Pennsylvania, 15025, United States
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Indiana, Pennsylvania, 15701, United States
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Lancaster, Pennsylvania, 17604, United States
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Philadelphia, Pennsylvania, 19106, United States
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Phoenixville, Pennsylvania, 19460, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Sewickley, Pennsylvania, 15143, United States
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Souderton, Pennsylvania, 18964, United States
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Uniontown, Pennsylvania, 15401, United States
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Warwick, Rhode Island, 02888, United States
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Columbia, South Carolina, 29203, United States
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Columbia, South Carolina, 29204, United States
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Greer, South Carolina, 29651, United States
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Jackson, Tennessee, 38301, United States
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Jackson, Tennessee, 38305, United States
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Memphis, Tennessee, 38104, United States
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Morristown, Tennessee, 37814, United States
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Amarillo, Texas, 79119, United States
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Fort Worth, Texas, 76104, United States
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Greenville, Texas, 75401, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77090, United States
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Lewisville, Texas, 75057, United States
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Longview, Texas, 75605, United States
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Odessa, Texas, 79761, United States
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Pasadena, Texas, 77504, United States
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Plano, Texas, 75075, United States
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San Antonio, Texas, 78229, United States
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Ogden, Utah, 84405, United States
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Salt Lake City, Utah, 84107, United States
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West Valley City, Utah, 84120, United States
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Alexandria, Virginia, 22306, United States
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Chesapeake, Virginia, 23320, United States
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Fairfax, Virginia, 22031, United States
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Norfolk, Virginia, 23502, United States
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Virginia Beach, Virginia, 23454, United States
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Winchester, Virginia, 22601, United States
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Seattle, Washington, 98133, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98405, United States
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Wenatchee, Washington, 98801, United States
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Milwaukee, Wisconsin, 53209, United States
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Monroe, Wisconsin, 53566, United States
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Abbotsford, British Columbia, V2S 3N5, Canada
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Guelph, Ontario, N1H 3R3, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2O4, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Québec, Quebec, G1L 3L5, Canada
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Québec, Quebec, G1S 4L8, Canada
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Ponce, 00717, Puerto Rico
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San Juan, 00936, Puerto Rico
Related Publications (1)
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.
PMID: 20064514DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grexan Wulff, Manager Regulatory Affairs
- Organization
- Warner Chilcott
Study Officials
- STUDY DIRECTOR
Tom G Todaro, MD
Procter and Gamble
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2007
First Posted
July 23, 2007
Study Start
July 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
April 22, 2013
Results First Posted
May 12, 2011
Record last verified: 2013-04