To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male and female patients, 16 to 75 years old, diagnosed with ulcerative colitis.
  • - 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 limited distal proctitis.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03412682
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ferring Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Global Clinical Compliance
Principal Investigator Affiliation Ferring Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ferring Investigator Site JPN25, Hiroshima-shi, Hiroshima, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN25

Hiroshima-shi, Hiroshima, ,

Ferring Investigator Site JPN16, Kofu-shi, Yamanashi, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN16

Kofu-shi, Yamanashi,

Ferring Investigator Site JPN45, Shinjuku-Ku, Tokyo, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN45

Shinjuku-Ku, Tokyo,

Ferring Investigator Site JPN54, Shinagawa-Ku, Tokyo, Japan

Status

Recruiting

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Ferring Investigator Site JPN54

Shinagawa-Ku, Tokyo,

Ferring Investigator Site JPN18, Oume-shi, Tokyo, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN18

Oume-shi, Tokyo,

Ferring Investigator Site JPN71, Mitaka-shi, Tokyo, Japan

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Recruiting

Address

Ferring Investigator Site JPN71

Mitaka-shi, Tokyo,

Ferring Investigator Site JPN58, Minato-ku, Tokyo, Japan

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Recruiting

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Ferring Investigator Site JPN58

Minato-ku, Tokyo,

Ferring Investigator site JPN06, Meguro-ku, Tokyo, Japan

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Recruiting

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Ferring Investigator site JPN06

Meguro-ku, Tokyo,

Ferring Investigator Site JPN15, Machida-shi, Tokyo, Japan

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Recruiting

Address

Ferring Investigator Site JPN15

Machida-shi, Tokyo,

Ferring Investigator Site JPN20, Kodaira-shi, Tokyo, Japan

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Recruiting

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Ferring Investigator Site JPN20

Kodaira-shi, Tokyo,

Ferring Investigator Site JPN32, Fuchū-shi, Tokyo, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN32

Fuchū-shi, Tokyo,

Ferring Investigator Site JPN70, Mibu, Tochigi, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN70

Mibu, Tochigi,

Ferring Investigator Site JPN56, Tokorozawa-shi, Saitama, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN56

Tokorozawa-shi, Saitama,

Ferring Investigator Site JPN42, Tokorozawa-shi, Saitama, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN42

Tokorozawa-shi, Saitama,

Ferring Investigator Site JPN49, Sakura-shi, Saitama, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN49

Sakura-shi, Saitama,

Ferring Investigator Site JPN09, Saitama-shi, Saitama, Japan

Status

Recruiting

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Ferring Investigator Site JPN09

Saitama-shi, Saitama,

Ferring Investigator Site JPN03, Saitama-shi, Saitama, Japan

Status

Recruiting

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Ferring Investigator Site JPN03

Saitama-shi, Saitama,

Ferring Investigator Site JPN57, Toyonaka-shi, Osaka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN57

Toyonaka-shi, Osaka,

Ferring Investigator Site JPN21, Takatsuki-shi, Osaka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN21

Takatsuki-shi, Osaka,

Ferring Investigator Site JPN39, Suita-shi, Osaka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN39

Suita-shi, Osaka,

Ferring Investigator Site JPN60, Sakai-shi, Osaka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN60

Sakai-shi, Osaka,

Ferring Investigator Site JPN30, Osaka-shi, Osaka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN30

Osaka-shi, Osaka,

Ferring Investigator Site JPN26, Osaka-shi, Osaka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN26

Osaka-shi, Osaka,

Ferring Investigator Site JPN10, Osaka-shi, Osaka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN10

Osaka-shi, Osaka,

Ferring Investigator site JPN07, Fujiidera-shi, Osaka, Japan

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Recruiting

Address

Ferring Investigator site JPN07

Fujiidera-shi, Osaka,

Ferring Investigator Site JPN65, Okayama-shi, Okayama, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN65

Okayama-shi, Okayama,

Ferring Investigator Site JPN01, Oita-shi, Oita, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN01

Oita-shi, Oita,

Ferring Investigator Site JPN37, Beppu-shi, Oita, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN37

Beppu-shi, Oita,

Ferring Investigator Site JPN55, Niigata-shi, Niigata, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN55

Niigata-shi, Niigata,

Ferring Investigator Site JPN62, Kashihara-shi, Nara, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN62

Kashihara-shi, Nara,

Ferring Investigator Site JPN66, Nagasaki-shi, Nagasaki, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN66

Nagasaki-shi, Nagasaki,

Ferring Investigator Site JPN44, Nagasaki-shi, Nagasaki, Japan

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Recruiting

Address

Ferring Investigator Site JPN44

Nagasaki-shi, Nagasaki,

Ferring Investigator site JPN04, Sendai-shi, Miyagi, Japan

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Recruiting

Address

Ferring Investigator site JPN04

Sendai-shi, Miyagi,

Ferring Investigator Site JPN12, Yokkaichi-shi, Mie, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN12

Yokkaichi-shi, Mie,

Ferring Investigator Site JPN48, Tsu-shi, Mie, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN48

Tsu-shi, Mie,

Ferring Investigator Site JPN34, Kyoto-shi, Kyoto, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN34

Kyoto-shi, Kyoto,

Ferring Investigator Site JPN63, Nankoku-shi, Kochi, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN63

Nankoku-shi, Kochi,

Ferring Investigator Site JPN67, Yokohama-shi, Kanagawa, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN67

Yokohama-shi, Kanagawa,

Ferring Investigator Site JPN33, Yokohama-shi, Kanagawa, Japan

Status

Recruiting

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Ferring Investigator Site JPN33

Yokohama-shi, Kanagawa,

Ferring Investigator site JPN05, Yokohama-shi, Kanagawa, Japan

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Recruiting

Address

Ferring Investigator site JPN05

Yokohama-shi, Kanagawa,

Ferring Investigator Site JPN29, Kagoshima-shi, Kagoshima, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN29

Kagoshima-shi, Kagoshima,

Ferring Investigator Site JPN02, Kagoshima-shi, Kagoshima, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN02

Kagoshima-shi, Kagoshima,

Ferring Investigator Site JPN41, Takamatsu-shi, Kagawa, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN41

Takamatsu-shi, Kagawa,

Ferring Investigator Site JPN22, Tsuchiura-shi, Ibaraki, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN22

Tsuchiura-shi, Ibaraki,

Ferring Investigator Site JPN24, Koga-shi, Ibaraki, Japan

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Recruiting

Address

Ferring Investigator Site JPN24

Koga-shi, Ibaraki,

Ferring Investigator Site JPN43, Kasama-shi, Ibaraki, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN43

Kasama-shi, Ibaraki,

Ferring Investigator Site JPN40, Nishinomiya-shi, Hyogo, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN40

Nishinomiya-shi, Hyogo,

Ferring Investigator Site JPN13, Nishinomiya-shi, Hyogo, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN13

Nishinomiya-shi, Hyogo,

Ferring Investigator Site JPN14, Kobe-shi, Hyogo, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN14

Kobe-shi, Hyogo,

Ferring Investigator Site JPN61, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN61

Sapporo-shi, Hokkaido,

Ferring Investigator Site JPN59, Hakodate-shi, Hokkaido, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN59

Hakodate-shi, Hokkaido,

Ferring Investigator Site JPN11, Asahikawa-shi, Hokkaido, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN11

Asahikawa-shi, Hokkaido,

Ferring Investigator Site JPN46, Hatsukaichi-city, Hiroshima, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN46

Hatsukaichi-city, Hiroshima,

Ferring Investigator Site JPN17, Takasaki-shi, Gunma, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN17

Takasaki-shi, Gunma,

Ferring Investigator Site JPN36, Gifu-city, Gifu, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN36

Gifu-city, Gifu,

Ferring Investigator Site JPN38, Kurume-shi, Fukuoka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN38

Kurume-shi, Fukuoka,

Ferring Investigator Site JPN35, Kitakyushu-shi, Fukuoka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN35

Kitakyushu-shi, Fukuoka,

Ferring Investigator Site JPN23, Kitakyushu-shi, Fukuoka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN23

Kitakyushu-shi, Fukuoka,

Ferring Investigator Site JPN19, Kitakyushu-shi, Fukuoka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN19

Kitakyushu-shi, Fukuoka,

Ferring Investigator Site JPN28, Kitakyushu-city, Fukuoka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN28

Kitakyushu-city, Fukuoka,

Ferring Investigator Site JPN64, Fukuoka-shi, Fukuoka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN64

Fukuoka-shi, Fukuoka,

Ferring Investigator Site JPN31, Fukuoka-shi, Fukuoka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN31

Fukuoka-shi, Fukuoka,

Ferring Investigator Site JPN51, Chikushino, Fukuoka, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN51

Chikushino, Fukuoka,

Ferring Investigator Site JPN50, Fukui-shi, Fukui, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN50

Fukui-shi, Fukui,

Ferring Investigator Site JPN08, Matsuyama-shi, Ehime, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN08

Matsuyama-shi, Ehime,

Ferring Investigator Site JPN53, Urayasu-shi, Chiba, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN53

Urayasu-shi, Chiba,

Ferring Investigator Site JPN68, Kashiwa-shi, Chiba, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN68

Kashiwa-shi, Chiba,

Ferring Investigator Site JPN69, Abiko-shi, Chiba, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN69

Abiko-shi, Chiba,

Ferring Investigator Site JPN47, Toyota-shi, Aichi, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN47

Toyota-shi, Aichi,

Ferring Investigator Site JPN52, Toyoake-shi, Aichi, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN52

Toyoake-shi, Aichi,

Ferring Investigator Site JPN27, Nagoya-shi, Aichi, Japan

Status

Recruiting

Address

Ferring Investigator Site JPN27

Nagoya-shi, Aichi,

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