To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis
NCT ID: NCT03412682
Last Updated: 2020-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
274 participants
INTERVENTIONAL
2018-03-02
2020-05-26
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
DOUBLE
Study Groups
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Budesonide (6 mg)
Budesonide (6 mg)
Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Budesonide (9 mg)
Budesonide (9 mg)
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)
Mesalazine (3,600 mg)
Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.
Interventions
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Budesonide (6 mg)
Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
Budesonide (9 mg)
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)
Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ulcerative colitis in active phase of mild to moderate entity.
* Female patients must fulfill at least one of the following criteria: Post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), surgically sterile, using a medically approved contraception throughout the trial period or her male partner using medically approved contraception throughout the trial period.
* Male patients must agree to use medically approved contraception throughout the trial period.
Exclusion Criteria
* Patients with infectious colitis.
* Patients with history of colectomy.
* Patients with severe diseases in other organs and systems.
* Evidence or history of toxic megacolon.
* Women who wish to become pregnant during the trial period
16 Years
75 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Ferring Investigator Site JPN27
Nagoya, Aichi-ken, Japan
Ferring Investigator Site JPN52
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
Countries
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Other Identifiers
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000234
Identifier Type: -
Identifier Source: org_study_id
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