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
PHASE2
108 participants
INTERVENTIONAL
2023-04-27
2024-10-18
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
QUADRUPLE
Study Groups
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KSP-0243
Under double-blinding, KSP 0243 tablets will be orally administered.
KSP-0243
Oral administration
Placebo
Under double-blinding, placebo tablets will be orally administered.
Placebo
Oral administration
Interventions
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KSP-0243
Oral administration
Placebo
Oral administration
Eligibility Criteria
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Inclusion Criteria
* Patients who have been given the diagnosis of ulcerative colitis for at least 12 weeks
* Patients with an endoscopic view typically seen with ulcerative colitis spreading \> 15 cm from the anal verge
* Patients with mild to moderate active ulcerative colitis who meet the certain conditions
* Patients who have an inadequate response to a fixed-dose oral 5-ASA formulation (mesalazine or salazosulfapyridine) continued from at least 2 weeks prior to the start of the screening period
Exclusion Criteria
* Patients who have or suspected to have bacterium- or parasite-induced infectious enteritis (e.g., infection with Clostridium difficile)
* Patients with any of the following concomitant illnesses with the severity considered inappropriate as a study patient by the principal investigator or the subinvestigator or medical history thereof:
* Hepatic or renal disorders or cardiovascular, endocrine, metabolic, pulmonary, gastrointestinal, neurological, urological, genitourinary, and immune diseases,
18 Years
74 Years
ALL
No
Sponsors
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Kissei Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yoshitaka Shimizu
Role: STUDY_DIRECTOR
Kissei Pharmaceutical Co., Ltd.
Locations
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Research Site
Multiple Locations, , Japan
Countries
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Other Identifiers
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0243CT02
Identifier Type: -
Identifier Source: org_study_id
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