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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-C000000289 |
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Date of registration:
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21/11/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Z-206 Phase III Clinical Trial - Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase -
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Scientific title:
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Z-206 Phase III Clinical Trial - Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase - - Z-206 Phase III Clinical Trial - Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase - |
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Date of first enrolment:
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2005/12/01 |
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Target sample size:
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120 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000362 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase III
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Countries of recruitment
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Japan
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Contacts
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Name:
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Toshifumi Hibi |
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Address:
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35 Shinano-Machi,Shinjuku-ku,Tokyo 160-8582,Japan
Japan |
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Telephone:
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Email:
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Affiliation:
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Keio University School of Medicine Department of Internal Medicine |
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Name:
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Zeria Pharmaceutical Co.,LTD. |
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Address:
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10-11,Nihonbashi,Kobuna-cho,Chuo-ku,Tokyo,103-8351,Japan
Japan |
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Telephone:
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Email:
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kaihatu@zeria.co.jp |
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Affiliation:
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Zeria Pharmaceutical Co.,LTD. Clinical Resarch |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal problem, injectable solution) within 14 days before start of administration of clinical study drug. 2)Patients who are administered immune-suppressing drug before start of administration of clinical study drug within 90 day. 3)Patients who are treated by blood cell apheresis within 14 days before start of administration of clinical study drug. 4)Patients with history of drug hypersensitivity to mesalazine formulation and drugs of salicylic acid groups. 5)Patients with liver disease or kidney disease (Each clinician will judge the presence or absence of liver disease or kidney disease.) 6)Patients with serious cardiovascular disease, hemodyscrasia or lung disease, or patients with history of serious cardiovascular disease, hemodyscrasia or lung disease. 7)Patients with malignant tumor as complication. 8)Pregnants, females who suckles, or females who wish to become pregnant. 9)Patients who are administered some kinds of clinical study drug within 6 months before obtaining informed consent. The clinical study drug administered in
Age minimum:
16years-old
Age maximum:
64years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Patients with ulcerative colitis in remission phase.
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Intervention(s)
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Z-206 group : Two Z-206 400 mg tablets, 3 tablets of Pentasa placebo tablet per time (total 5 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks.
Mesalazine group: Three tablets of Pentasa 250 mg tablet and 2 tablets of Z-206 placebo tablet per time (total 5 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks.
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Primary Outcome(s)
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Non-incidence of bloody stool
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Secondary Outcome(s)
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Period of non-emergence of bloody stool. Non-recurrence rates. Period of non-recurrence of bloody stool, and change of UC-DAI.
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Source(s) of Monetary Support
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Zeria Pharmaceutical Co.,LTD.
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/09/2007 |
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URL:
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