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軽度から中等度の活動性潰瘍性大腸炎を有する日本人被験者におけるFE 999315の有効性および安全性を評価する

基本情報

NCT ID
NCT03412682
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
274
治験依頼者名
Ferring Pharmaceuticals

概要

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.

対象疾患

Colitis, Ulcerative

介入

Budesonide (6 mg)(DRUG)
Budesonide (9 mg)(DRUG)
Mesalazine (3,600 mg)(DRUG)

依頼者(Sponsor)

Ferring(INDUSTRY)

実施施設 (50)

Ferring Investigator Site JPN13

Nishinomiya-shi, Hyōgo, Japan

Ferring Investigator Site JPN44

Nagasaki, Nagasaki, Japan

Ferring Investigator Site JPN68

Kashiwa-shi, Chiba, Japan

Ferring Investigator Site JPN01

Ōita, Oita Prefecture, Japan

Ferring Investigator Site JPN57

Toyonaka-shi, Osaka, Japan

Ferring Investigator Site JPN71

Mitaka-shi, Tokyo, Japan

Ferring Investigator Site JPN70

Mibu, Tochigi, Japan

Ferring Investigator Site JPN22

Tsuchiura-shi, Ibaraki, Japan

Ferring Investigator Site JPN14

Kobe, Hyōgo, Japan

Ferring Investigator Site JPN18

Oume-shi, Tokyo, Japan

Ferring Investigator Site JPN26

Osaka, Osaka, Japan

Ferring Investigator Site JPN64

Fukuoka, Fukuoka, Japan

Ferring Investigator Site JPN55

Niigata, Niigata, Japan

Ferring Investigator Site JPN09

Saitama-shi, Saitama, Japan

Ferring Investigator Site JPN63

Nankoku-shi, Kochi, Japan

Ferring Investigator Site JPN47

Toyota-shi, Aichi-ken, Japan

Ferring Investigator Site JPN30

Osaka, Osaka, Japan

Ferring Investigator Site JPN12

Yokkaichi-shi, Mie-ken, Japan

Ferring Investigator Site JPN58

Minato-ku, Tokyo, Japan

Ferring Investigator Site JPN72

Ōita, Oita Prefecture, Japan

Ferring Investigator Site JPN39

Suita-shi, Osaka, Japan

Ferring Investigator Site JPN38

Kurume-shi, Fukuoka, Japan

Ferring Investigator Site JPN19

Kitakyushu-shi, Fukuoka, Japan

Ferring Investigator site JPN05

Yokohama, Kanagawa, Japan

Ferring Investigator site JPN07

Fujiidera-shi, Osaka, Japan

Ferring Investigator Site JPN17

Takasaki-shi, Gunma, Japan

Ferring Investigator site JPN06

Meguro-ku, Tokyo, Japan

Ferring Investigator Site JPN35

Kitakyushu-shi, Fukuoka, Japan

Ferring Investigator Site JPN20

Kodaira-shi, Tokyo, Japan

Ferring Investigator Site JPN61

Sapporo, Hokkaido, Japan

Ferring Investigator Site JPN34

Kyoto, Kyoto, Japan

Ferring Investigator Site JPN43

Kasama-shi, Ibaraki, Japan

Ferring Investigator Site JPN11

Asahikawa-shi, Hokkaido, Japan

Ferring Investigator Site JPN23

Kitakyushu-shi, Fukuoka, Japan

Ferring Investigator Site JPN51

Chikushino-shi, Fukuoka, Japan

Ferring Investigator Site JPN53

Urayasu-shi, Chiba, Japan

Ferring Investigator Site JPN49

Sakura-shi, Saitama, Japan

Ferring Investigator Site JPN52

Toyoake-shi, Aichi-ken, Japan

Ferring Investigator Site JPN25

Hiroshima-shi, Hiroshima, Japan

Ferring Investigator Site JPN16

Kofu, Yamanashi, Japan

Ferring Investigator site JPN04

Sendai, Miyagi, Japan

Ferring Investigator Site JPN27

Nagoya, Aichi-ken, Japan

Ferring Investigator Site JPN33

Yokohama, Kanagawa, Japan

Ferring Investigator Site JPN67

Yokohama, Kanagawa, Japan

Ferring Investigator Site JPN65

Okayama, Okayama-ken, Japan

Ferring Investigator Site JPN37

Beppu-shi, Oita Prefecture, Japan

Ferring Investigator Site JPN10

Osaka, Osaka, Japan

Ferring Investigator Site JPN48

Tsu, Mie-ken, Japan

Ferring Investigator Site JPN46

Hatsukaichi, Hiroshima, Japan

Ferring Investigator Site JPN50

Fukui-shi, Fukui, Japan