- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00505778
En sammenligning af dosis én gang om dagen sammenlignet med 2 doser om dagen
15. april 2013 opdateret af: Warner Chilcott
Et multicenter, investigator-blindet, randomiseret, 12-måneders, parallel-gruppe, non-inferioritetsstudie for at sammenligne effektiviteten af 1,6 til 2,4 g Asacol® terapi QD versus divideret dosis (BID) i opretholdelse af remission af colitis ulcerosa
Formålet med denne undersøgelse er at sammenligne effektiviteten til at opretholde remission af colitis ulcerosa mellem et Asacol-regimen én gang dagligt (QD) og et opdelt, to gange dagligt (BID) Asacol-doseringsregimen.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
I USA er Asacol-behandling i øjeblikket indiceret i opdelte doser til opretholdelse af remission af colitis ulcerosa med 1,6 g/dag.
En dosis én gang dagligt er potentielt gavnlig for både patienter og læger.
Denne undersøgelse vil besvare følgende spørgsmål om dosering én gang dagligt: (1) adskiller effektiviteten sig mellem én gang daglig og to gange daglig dosering, (2) foretrækker patienter en én gang daglig dosering, og (3) er compliance bedre?
Denne undersøgelse vil bekræfte, om der er fordele ved dosering én gang dagligt ud over øget bekvemmelighed.
For at forstå, hvordan QD-kuren kan sammenlignes med BID i et "virkelig liv" praksis, vil patienten forblive på den samlede daglige dosis af Asacol (1,6 g/dag til 2,4 g/dag), hvor de blev holdt i remission, men vil blive tildelt enten en QD- eller BID-kur.
Dette er en efterforsker-blindet undersøgelse.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1027
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Quebec, Canada, G1L 3L5
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Quebec, Canada, G1S 4L8
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British Columbia
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Abbotsford, British Columbia, Canada, V2S 3N5
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Ontario
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Guelph, Ontario, Canada, N1H 3R3
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Hamilton, Ontario, Canada, L8N 4A6
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M5G 2O4
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H3T 1E2
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Alabama
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Athens, Alabama, Forenede Stater, 35611
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Birmingham, Alabama, Forenede Stater, 35209
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Birmingham, Alabama, Forenede Stater, 35294
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Dothan, Alabama, Forenede Stater, 26305-1156
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Arizona
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Phoenix, Arizona, Forenede Stater, 85050
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Scottsdale, Arizona, Forenede Stater, 85259
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Tucson, Arizona, Forenede Stater, 85712
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Tuscon, Arizona, Forenede Stater, 85711
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
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Lowell, Arkansas, Forenede Stater, 72745
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California
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Anaheim, California, Forenede Stater, 92801
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Beverly Hills, California, Forenede Stater, 90210
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Chico, California, Forenede Stater, 95926
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Encinitas, California, Forenede Stater, 92024
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Folsum, California, Forenede Stater, 95630
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La Mesa, California, Forenede Stater, 91941
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Lancaster, California, Forenede Stater, 93534
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Long Beach, California, Forenede Stater, 90806
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Los Angeles, California, Forenede Stater, 90015
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Los Angeles, California, Forenede Stater, 90045
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Madera, California, Forenede Stater, 93637
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Merced, California, Forenede Stater, 95340
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Mission Hills, California, Forenede Stater, 91345
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Monterey, California, Forenede Stater, 93940
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Murrieta, California, Forenede Stater, 92562
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Oakland, California, Forenede Stater, 94609
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Orange, California, Forenede Stater, 92868
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Palm Springs, California, Forenede Stater, 92262
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San Carlos, California, Forenede Stater, 94070
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San Diego, California, Forenede Stater, 92123
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San Diego, California, Forenede Stater, 92103
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San Diego, California, Forenede Stater, 92117
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San Francisco, California, Forenede Stater, 94117
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San Francisco, California, Forenede Stater, 94122
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Torrance, California, Forenede Stater, 90503
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Torrance, California, Forenede Stater, 90505
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Upland, California, Forenede Stater, 91786
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Colorado
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Englewood, Colorado, Forenede Stater, 80113
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Golden, Colorado, Forenede Stater, 80401
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Lafayette, Colorado, Forenede Stater, 80026
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Pueblo, Colorado, Forenede Stater, 81008
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06106
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Meriden, Connecticut, Forenede Stater, 06451
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New Haven, Connecticut, Forenede Stater, 06510
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Norwalk, Connecticut, Forenede Stater, 06851
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Torrington, Connecticut, Forenede Stater, 06790
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20060
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Florida
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Aventura, Florida, Forenede Stater, 33180
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Fort Lauderdale, Florida, Forenede Stater, 33308
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Gainesville, Florida, Forenede Stater, 32607
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Hollywood, Florida, Forenede Stater, 33021
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Jacksonville, Florida, Forenede Stater, 32207
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Jacksonville, Florida, Forenede Stater, 32223
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Largo, Florida, Forenede Stater, 33777
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Maitland, Florida, Forenede Stater, 32751
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Naples, Florida, Forenede Stater, 34102
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New Port Richey, Florida, Forenede Stater, 34652
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North Miami Beach, Florida, Forenede Stater, 33162
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Orlando, Florida, Forenede Stater, 32806
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Palm Harbor, Florida, Forenede Stater, 34684
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Port Orange, Florida, Forenede Stater, 32129
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St Petersburg, Florida, Forenede Stater, 33711
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St. Petersburg, Florida, Forenede Stater, 33707
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Tallahassee, Florida, Forenede Stater, 32308
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Tampa, Florida, Forenede Stater, 33613
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Tampa, Florida, Forenede Stater, 33607
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Trinity, Florida, Forenede Stater, 34655
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Winter Park, Florida, Forenede Stater, 32789
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Zephyrhills, Florida, Forenede Stater, 33542
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342-5000
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Columbus, Georgia, Forenede Stater, 31904
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Decatur, Georgia, Forenede Stater, 30033
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Marietta, Georgia, Forenede Stater, 30060
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Marietta, Georgia, Forenede Stater, 30067
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Newnan, Georgia, Forenede Stater, 30263
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Savannah, Georgia, Forenede Stater, 31406
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Idaho
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Boise, Idaho, Forenede Stater, 83704
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Idaho Falls, Idaho, Forenede Stater, 83404
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
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Berwyn, Illinois, Forenede Stater, 60402
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Chicago, Illinois, Forenede Stater, 60637
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Elgin, Illinois, Forenede Stater, 60123
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Highland Park, Illinois, Forenede Stater, 60036
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Hoffman Estates, Illinois, Forenede Stater, 60169
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Homewood, Illinois, Forenede Stater, 60430
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Lake Barrington, Illinois, Forenede Stater, 60010
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Oak Lawn, Illinois, Forenede Stater, 60453
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Peoria, Illinois, Forenede Stater, 61602
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Urbana, Illinois, Forenede Stater, 61801
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Indiana
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Anderson, Indiana, Forenede Stater, 46016
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Bloomington, Indiana, Forenede Stater, 47403
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Indianapolis, Indiana, Forenede Stater, 46202
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Indianapolis, Indiana, Forenede Stater, 46260
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South Bend, Indiana, Forenede Stater, 46601
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Iowa
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Clive, Iowa, Forenede Stater, 50325
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Davenport, Iowa, Forenede Stater, 52807
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Waterloo, Iowa, Forenede Stater, 50701
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Kansas
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Pratt, Kansas, Forenede Stater, 67124
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Topeka, Kansas, Forenede Stater, 66606
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Whichita, Kansas, Forenede Stater, 67214
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Kentucky
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Bowling Green, Kentucky, Forenede Stater, 42101
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Louisville, Kentucky, Forenede Stater, 40202
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Louisville, Kentucky, Forenede Stater, 40291
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Louisiana
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Alexandria, Louisiana, Forenede Stater, 71301
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Lafayette, Louisiana, Forenede Stater, 70503
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Metairie, Louisiana, Forenede Stater, 70006
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Monroe, Louisiana, Forenede Stater, 71201
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Shreveport, Louisiana, Forenede Stater, 71103
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Maine
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Bangor, Maine, Forenede Stater, 04401
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Maryland
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Chevy Chase, Maryland, Forenede Stater, 20815
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College Park, Maryland, Forenede Stater, 20740
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Greenbelt, Maryland, Forenede Stater, 20770
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Hagerstown, Maryland, Forenede Stater, 21740
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Hollywood, Maryland, Forenede Stater, 20636
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Lutherville, Maryland, Forenede Stater, 21093
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Reisterstown, Maryland, Forenede Stater, 21136
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Rockville, Maryland, Forenede Stater, 20850
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Rockville, Maryland, Forenede Stater, 20854
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
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Boston, Massachusetts, Forenede Stater, 02215
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Braintree, Massachusetts, Forenede Stater, 02184
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Southbridge, Massachusetts, Forenede Stater, 01550
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Michigan
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Chesterfield, Michigan, Forenede Stater, 48047
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Detroit, Michigan, Forenede Stater, 48201
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Kalamazoo, Michigan, Forenede Stater, 49048
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Troy, Michigan, Forenede Stater, 48098
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West Bloomfied, Michigan, Forenede Stater, 48322
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Wyoming, Michigan, Forenede Stater, 49519
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
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Mississippi
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Tupelo, Mississippi, Forenede Stater, 38801
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703-6364
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Columbia, Missouri, Forenede Stater, 65212
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Jefferson City, Missouri, Forenede Stater, 65109
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Mexico, Missouri, Forenede Stater, 65265
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St Louis, Missouri, Forenede Stater, 63128
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89147
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New Hampshire
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Somersworth, New Hampshire, Forenede Stater, 03878
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
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Cedar Knolls, New Jersey, Forenede Stater, 07927
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Egg Harbor Township, New Jersey, Forenede Stater, 08234-5857
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Hackensack, New Jersey, Forenede Stater, 07601
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Ocean, New Jersey, Forenede Stater, 07712
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South Plainfield, New Jersey, Forenede Stater, 07080
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
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New York
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Babylon, New York, Forenede Stater, 11702
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Binghamton, New York, Forenede Stater, 13903
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Brooklyn, New York, Forenede Stater, 11215
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Brooklyn, New York, Forenede Stater, 11234
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Cheektowaga, New York, Forenede Stater, 14225
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Cortland, New York, Forenede Stater, 13045
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Forest Hills, New York, Forenede Stater, 10128
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Garden City, New York, Forenede Stater, 11530
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Great Neck, New York, Forenede Stater, 11021
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Great Neck, New York, Forenede Stater, 11023
- Research Facility
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Lake Success, New York, Forenede Stater, 11042
- Research Facility
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New York, New York, Forenede Stater, 10016
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New York, New York, Forenede Stater, 10028
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Pittsford, New York, Forenede Stater, 14534
- Research Facility
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Port Jefferson Station, New York, Forenede Stater, 11776
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Rochester, New York, Forenede Stater, 14621
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Rochester, New York, Forenede Stater, 14625
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North Carolina
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Boone, North Carolina, Forenede Stater, 28607
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Charlotte, North Carolina, Forenede Stater, 28204
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Greensboro, North Carolina, Forenede Stater, 27403
- Research Facility
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Greenville, North Carolina, Forenede Stater, 27834
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Jacksonville, North Carolina, Forenede Stater, 28546
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Kinston, North Carolina, Forenede Stater, 28501
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Morganton, North Carolina, Forenede Stater, 28655
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Mt Airy, North Carolina, Forenede Stater, 27030
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Newbern, North Carolina, Forenede Stater, 28562
- Research Facility
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Pinehurst, North Carolina, Forenede Stater, 28374
- Research Facility
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Raleigh, North Carolina, Forenede Stater, 27607
- Research Facility
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Wilmington, North Carolina, Forenede Stater, 28401
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
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Ohio
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Akron, Ohio, Forenede Stater, 44302
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Canton, Ohio, Forenede Stater, 44718
- Research Facility
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Cincinnati, Ohio, Forenede Stater, 45242
- Research Facility
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Cincinnati, Ohio, Forenede Stater, 45219
- Research Facility
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Cleveland, Ohio, Forenede Stater, 44195
- Research Facility
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Dayton, Ohio, Forenede Stater, 45440
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Dayton, Ohio, Forenede Stater, 45415
- Research Facility
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Mentor, Ohio, Forenede Stater, 44060
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Toledo, Ohio, Forenede Stater, 43617
- Research Facility
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Westlake, Ohio, Forenede Stater, 44145
- Research Facility
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74104
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Oregon
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Portland, Oregon, Forenede Stater, 97225
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18104
- Research Facility
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Beaver Falls, Pennsylvania, Forenede Stater, 15010
- Research Facility
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Clairton, Pennsylvania, Forenede Stater, 15025
- Research Facility
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Indiana, Pennsylvania, Forenede Stater, 15701
- Research Facility
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Lancaster, Pennsylvania, Forenede Stater, 17604
- Research Facility
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Philadelphia, Pennsylvania, Forenede Stater, 19106
- Research Facility
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Phoenixville, Pennsylvania, Forenede Stater, 19460
- Research Facility
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Research Facility
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Pittsburgh, Pennsylvania, Forenede Stater, 15243
- Research Facility
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Sewickley, Pennsylvania, Forenede Stater, 15143
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Souderton, Pennsylvania, Forenede Stater, 18964
- Research Facility
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Uniontown, Pennsylvania, Forenede Stater, 15401
- Research Facility
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Rhode Island
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Warwick, Rhode Island, Forenede Stater, 02888
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29203
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Columbia, South Carolina, Forenede Stater, 29204
- Research Facility
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Greer, South Carolina, Forenede Stater, 29651
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Tennessee
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Jackson, Tennessee, Forenede Stater, 38301
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Jackson, Tennessee, Forenede Stater, 38305
- Research Facility
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Memphis, Tennessee, Forenede Stater, 38104
- Research Facility
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Morristown, Tennessee, Forenede Stater, 37814
- Research Facility
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Texas
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Amarillo, Texas, Forenede Stater, 79119
- Research Facility
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Fort Worth, Texas, Forenede Stater, 76104
- Research Facility
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Greenville, Texas, Forenede Stater, 75401
- Research Facility
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Houston, Texas, Forenede Stater, 77054
- Research Facility
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Houston, Texas, Forenede Stater, 77004
- Research Facility
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Houston, Texas, Forenede Stater, 77090
- Research Facility
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Lewisville, Texas, Forenede Stater, 75057
- Research Facility
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Longview, Texas, Forenede Stater, 75605
- Research Facility
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Odessa, Texas, Forenede Stater, 79761
- Research Facility
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Pasadena, Texas, Forenede Stater, 77504
- Research Facility
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Plano, Texas, Forenede Stater, 75075
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San Antonio, Texas, Forenede Stater, 78229
- Research Facility
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Utah
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Ogden, Utah, Forenede Stater, 84405
- Research Facility
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Salt Lake City, Utah, Forenede Stater, 84107
- Research Facility
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West Valley City, Utah, Forenede Stater, 84120
- Research Facility
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Virginia
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Alexandria, Virginia, Forenede Stater, 22306
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Chesapeake, Virginia, Forenede Stater, 23320
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Fairfax, Virginia, Forenede Stater, 22031
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Norfolk, Virginia, Forenede Stater, 23502
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Virginia Beach, Virginia, Forenede Stater, 23454
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Winchester, Virginia, Forenede Stater, 22601
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Washington
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Seattle, Washington, Forenede Stater, 98133
- Research Facility
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Spokane, Washington, Forenede Stater, 99204
- Research Facility
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Tacoma, Washington, Forenede Stater, 98405
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Wenatchee, Washington, Forenede Stater, 98801
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53209
- Research Facility
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Monroe, Wisconsin, Forenede Stater, 53566
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Ponce, Puerto Rico, 00717
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San Juan, Puerto Rico, 00936
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Dokumenteret historie med colitis ulcerosa, der med succes er blevet holdt i remission i mindst 3 måneder før studiestart
- Mindst én udbrud inden for de seneste 18 måneder
- Brug af en stabil vedligeholdelsesdosis af oral Asacol på 1,6 g/dag op til 2,4 g/dag (stabil dosis er defineret som den samme dosis i de sidste 3 måneder)
- Kvinder skal være postmenopausale eller kirurgisk sterile eller have en negativ uringraviditetstest og anvende acceptabel prævention
Ekskluderingskriterier:
- Anamnese med eller nuværende nyresygdom
- Anamnese med leversygdom
- Anamnese med allergi eller overfølsomhed over for salicylater, aminosalicylater
- Behandling med immunmodulerende terapi, biologisk terapi eller kortikosteroider inden for 90 dage efter screening
- Modtaget antidiarré, krampestillende eller antibiotika inden for 1 måned efter screening
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Mesalamin (Asacol) én gang dagligt
en oral, én gang daglig (QD) mesalamin-kur (1,6 - 2,4 g/dag)
|
Mesalamin tabletter, 1,6-2,4
g/dag indtaget oralt én gang dagligt i 52 uger
Andre navne:
|
|
Aktiv komparator: Mesalamin (Asacol) to gange dagligt
en oral, to gange daglig (BID) mesalamin-kur (1,6 - 2,4 g/dag)
|
Mesalamin tabletter, 1,6-2,4
g/dag, taget to gange dagligt i 52 uger
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af patienter, der forbliver i remission ved 6. måned, ITT-population, bestemt af Simple Clinical Colitis Activity Index (SCCAI)
Tidsramme: 6 måneder
|
Remission defineret som SCCAI <5.
Simple Clinical Colitis Activity Index: minimumscore 0, maksimumscore 19, afspejler sygdomsaktivitet over de 24 timer før afslutning.
Sammensat score: tarmfrekvens (dag, 0-3) (nat, 0-2), hastende afføring (0-3), blod i afføringen (0-3), generel velvære (0-4), ekstrakoloniske træk (gigt , pyoderma gangrenosum, erythema nodosum, uveitis - 1 pr. manifestation).
|
6 måneder
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af patienter, der forbliver i remission ved 3. måned, ITT-population
Tidsramme: 3 måneder
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Remission defineret som SCCAI < 5. Simple Clinical Colitis Activity Index: minimumscore 0, maksimumscore 19, afspejler sygdomsaktivitet over de 24 timer før afslutning.
Sammensat score: tarmfrekvens (dag, 0-3) (nat, 0-2), hastende afføring (0-3), blod i afføringen (0-3), generel velvære (0-4), ekstrakoloniske træk (gigt , pyoderma gangrenosum, erythema nodosum, uveitis - 1 pr. manifestation).
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3 måneder
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Procentdel af patienter, der forbliver i remission ved 12. måned, ITT-population
Tidsramme: 12 måneder
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Remission defineret som SCCAI-score < 5. Simple Clinical Colitis Activity Index: minimumscore 0, maksimumscore 19, afspejler sygdomsaktivitet over de 24 timer før afslutning.
Sammensat score: tarmfrekvens (dag, 0-3) (nat, 0-2), hastende afføring (0-3), blod i afføringen (0-3), generel velvære (0-4), ekstrakoloniske træk (gigt , pyoderma gangrenosum, erythema nodosum, uveitis - 1 pr. manifestation).
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12 måneder
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Antal forsøgspersoner, der får tilbagefald/opblussen inden for 6 måneder, ITT-population
Tidsramme: 6 måneder
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Tilbagefald/opblussen er defineret som SCCAI >= 5. Simple Clinical Colitis Activity Index: minimumscore 0, maksimumscore 19, afspejler sygdomsaktivitet over de 24 timer før afslutning.
Sammensat score: tarmfrekvens (dag, 0-3) (nat, 0-2), hastende afføring (0-3), blod i afføringen (0-3), generel velvære (0-4), ekstrakoloniske træk (gigt , pyoderma gangrenosum, erythema nodosum, uveitis - 1 pr. manifestation).
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6 måneder
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Total MARS (Medication Adherence Report Scale) Spørgeskemaresultater, ITT-population, måned 6
Tidsramme: 6 måneder
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MARS: Sammensat score for følgende udsagn: Jeg ændrer, hvor mange gange om dagen jeg tager min medicin, jeg glemmer at bruge den, jeg stopper med at tage den i et stykke tid, jeg bruger den kun, når jeg har aktive symptomer, jeg beslutter mig for at gå glip af ud på en dosis, jeg tager mindre end anvist, jeg tager mere end anvist, jeg undgår at bruge den, hvis jeg kan, jeg bruger den regelmæssigt hver dag (omvendt score): 5-aldrig, 4-sjældent, 3-nogle gange, 2- ofte, 1-meget ofte.
Minimumscore 9, maksimumscore 45.
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6 måneder
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Procentdel af deltagere, der indikerer colitis ulcerosa i remission (patientdefineret remissionsindeks), ITT-population, måned 6
Tidsramme: 6 måneder
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Er din colitis ulcerosa i remission (ikke aktiv)?
J/N
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6 måneder
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Tom G Todaro, MD, Procter and Gamble
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2007
Primær færdiggørelse (Faktiske)
1. juli 2009
Studieafslutning (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først indsendt
20. juli 2007
Først indsendt, der opfyldte QC-kriterier
20. juli 2007
Først opslået (Skøn)
23. juli 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. april 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. april 2013
Sidst verificeret
1. april 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Patologiske processer
- Gastrointestinale sygdomme
- Gastroenteritis
- Tyktarmssygdomme
- Tarmsygdomme
- Inflammatoriske tarmsygdomme
- Mavesår
- Colitis
- Colitis, Ulcerativ
- Lægemidlers fysiologiske virkninger
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Mesalamin
Andre undersøgelses-id-numre
- 2007021
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .