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To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide (6 mg) | Experimental |
| |
| Budesonide (9 mg) | Experimental |
| |
| Mesalazine (3,600 mg) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide (6 mg) | Drug | Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score | UCDAI is a four-component scale, used to determine the severity of ulcerative colitis. The four components assessed are stool frequency, rectal bleeding, mucosal appearance and physician's rating of disease activity. Score for each component can range between 0-3 and thus, the maximum overall score can be between 0-12. Higher score implies higher disease severity. | After 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving clinical remission after 8 weeks of treatment | 8 weeks | |
| Percentage of subjects achieving 0 score for subscores of rectal bleeding, stool frequency and mucosal appearance (normal mucosa) in UCDAI after 8 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferring Investigator Site JPN27 | Nagoya | Aichi-ken | Japan | |||
| Ferring Investigator Site JPN52 |
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|
| Budesonide (9 mg) | Drug | Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period. |
|
|
| Mesalazine (3,600 mg) | Drug | Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period. |
|
| 8 weeks |
| Percentage of subjects achieving clinical improvement after 8 weeks of treatment | 8 weeks |
| Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1 | 8 weeks |
| Percentage of subjects achieving symptom resolution after 2 weeks of treatment | 2 weeks |
| Percentage of subjects achieving symptom resolution after 4 weeks of treatment | 4 weeks |
| Percentage of subjects achieving symptom resolution after 8 weeks of treatment | 8 weeks |
| Percentage of subjects with endoscopic healing after 8 weeks of treatment | 8 weeks |
| Change from baseline in partial UCDAI score at 2 weeks | 2 weeks |
| Change from baseline in partial UCDAI score at 4 weeks | 4 weeks |
| Change from baseline in partial UCDAI score at 8 weeks | 8 weeks |
| Toyoake-shi |
| Aichi-ken |
| Japan |
| Ferring Investigator Site JPN47 | Toyota-shi | Aichi-ken | Japan |
| Ferring Investigator Site JPN69 | Abiko-shi | Chiba | Japan |
| Ferring Investigator Site JPN68 | Kashiwa-shi | Chiba | Japan |
| Ferring Investigator Site JPN53 | Urayasu-shi | Chiba | Japan |
| Ferring Investigator Site JPN08 | Matsuyama | Ehime | Japan |
| Ferring Investigator Site JPN50 | Fukui-shi | Fukui | Japan |
| Ferring Investigator Site JPN51 | Chikushino-shi | Fukuoka | Japan |
| Ferring Investigator Site JPN31 | Fukuoka | Fukuoka | Japan |
| Ferring Investigator Site JPN64 | Fukuoka | Fukuoka | Japan |
| Ferring Investigator Site JPN28 | Kitakyushu | Fukuoka | Japan |
| Ferring Investigator Site JPN19 | Kitakyushu-shi | Fukuoka | Japan |
| Ferring Investigator Site JPN23 | Kitakyushu-shi | Fukuoka | Japan |
| Ferring Investigator Site JPN35 | Kitakyushu-shi | Fukuoka | Japan |
| Ferring Investigator Site JPN38 | Kurume-shi | Fukuoka | Japan |
| Ferring Investigator Site JPN36 | Gifu | Gifu | Japan |
| Ferring Investigator Site JPN17 | Takasaki-shi | Gunma | Japan |
| Ferring Investigator Site JPN46 | Hatsukaichi | Hiroshima | Japan |
| Ferring Investigator Site JPN11 | Asahikawa-shi | Hokkaido | Japan |
| Ferring Investigator Site JPN59 | Hakodate-shi | Hokkaido | Japan |
| Ferring Investigator Site JPN61 | Sapporo | Hokkaido | Japan |
| Ferring Investigator Site JPN14 | Kobe | Hyōgo | Japan |
| Ferring Investigator Site JPN13 | Nishinomiya-shi | Hyōgo | Japan |
| Ferring Investigator Site JPN40 | Nishinomiya-shi | Hyōgo | Japan |
| Ferring Investigator Site JPN43 | Kasama-shi | Ibaraki | Japan |
| Ferring Investigator Site JPN24 | Koga-shi | Ibaraki | Japan |
| Ferring Investigator Site JPN22 | Tsuchiura-shi | Ibaraki | Japan |
| Ferring Investigator Site JPN41 | Takamatsu | Kagawa-ken | Japan |
| Ferring Investigator Site JPN02 | Kagoshima | Kagoshima-ken | Japan |
| Ferring Investigator Site JPN29 | Kagoshima | Kagoshima-ken | Japan |
| Ferring Investigator site JPN05 | Yokohama | Kanagawa | Japan |
| Ferring Investigator Site JPN33 | Yokohama | Kanagawa | Japan |
| Ferring Investigator Site JPN67 | Yokohama | Kanagawa | Japan |
| Ferring Investigator Site JPN63 | Nankoku-shi | Kochi | Japan |
| Ferring Investigator Site JPN34 | Kyoto | Kyoto | Japan |
| Ferring Investigator Site JPN48 | Tsu | Mie-ken | Japan |
| Ferring Investigator Site JPN12 | Yokkaichi-shi | Mie-ken | Japan |
| Ferring Investigator site JPN04 | Sendai | Miyagi | Japan |
| Ferring Investigator Site JPN44 | Nagasaki | Nagasaki | Japan |
| Ferring Investigator Site JPN66 | Nagasaki | Nagasaki | Japan |
| Ferring Investigator Site JPN62 | Kashihara-shi | Nara | Japan |
| Ferring Investigator Site JPN55 | Niigata | Niigata | Japan |
| Ferring Investigator Site JPN37 | Beppu-shi | Oita Prefecture | Japan |
| Ferring Investigator Site JPN01 | Ōita | Oita Prefecture | Japan |
| Ferring Investigator Site JPN72 | Ōita | Oita Prefecture | Japan |
| Ferring Investigator Site JPN65 | Okayama | Okayama-ken | Japan |
| Ferring Investigator site JPN07 | Fujiidera-shi | Osaka | Japan |
| Ferring Investigator Site JPN10 | Osaka | Osaka | Japan |
| Ferring Investigator Site JPN26 | Osaka | Osaka | Japan |
| Ferring Investigator Site JPN30 | Osaka | Osaka | Japan |
| Ferring Investigator Site JPN60 | Sakai-shi | Osaka | Japan |
| Ferring Investigator Site JPN39 | Suita-shi | Osaka | Japan |
| Ferring Investigator Site JPN21 | Takatsuki-shi | Osaka | Japan |
| Ferring Investigator Site JPN57 | Toyonaka-shi | Osaka | Japan |
| Ferring Investigator Site JPN03 | Saitama-shi | Saitama | Japan |
| Ferring Investigator Site JPN09 | Saitama-shi | Saitama | Japan |
| Ferring Investigator Site JPN49 | Sakura-shi | Saitama | Japan |
| Ferring Investigator Site JPN42 | Tokorozawa-shi | Saitama | Japan |
| Ferring Investigator Site JPN56 | Tokorozawa-shi | Saitama | Japan |
| Ferring Investigator Site JPN70 | Mibu | Tochigi | Japan |
| Ferring Investigator Site JPN32 | Fuchū-shi | Tokyo | Japan |
| Ferring Investigator Site JPN20 | Kodaira-shi | Tokyo | Japan |
| Ferring Investigator Site JPN15 | Machida-shi | Tokyo | Japan |
| Ferring Investigator site JPN06 | Meguro-ku | Tokyo | Japan |
| Ferring Investigator Site JPN58 | Minato-ku | Tokyo | Japan |
| Ferring Investigator Site JPN71 | Mitaka-shi | Tokyo | Japan |
| Ferring Investigator Site JPN18 | Oume-shi | Tokyo | Japan |
| Ferring Investigator Site JPN54 | Shinagawa-Ku | Tokyo | Japan |
| Ferring Investigator Site JPN45 | Shinjuku-Ku | Tokyo | Japan |
| Ferring Investigator Site JPN16 | Kofu | Yamanashi | Japan |
| Ferring Investigator Site JPN25 | Hiroshima-shi, Hiroshima | Japan |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003092 | Colitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
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