Z-206 Phase III Clinical Trial - Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase -

UMIN ID: C000000288

Registered date:21/11/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with ulcerative colitis in active phase
• Date of first enrollment: 2005/12/01
• Target sample size: 210
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Z-206 2.4g/day dose group: Two Z-206 400mg tablets, 1 tablet of Z-206 placebo tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks.
Z-206 3.6g/day dose group: Three tablets of Z-206 400mg tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks.
Mesalazine group: Three tablets of Pentasa 250 mg tablet and 3 tablets of Z-206 placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks.
Placebo group: Three tablets of Z-206 placebo tablet and 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks.

Outcome(s)

• Primary Outcome: Reduction degree of UC-DAI
• Secondary Outcome: Reduction degree of score of each UC-DAI item. Remission rate. Efficacy rate.

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: 1)Patients with serious according to diagnostic criteria of seriousness and patients with chronic persistent type and with acute serious type in the classification by clinical course are to be excluded. 2)Patients who take mesalazine oral formulation with a dosage of 2.25 g/day within 14 days before initiation of the study drug, or patients with who take salazosulfapyrdine oral formulation with a dosage of 4.5 g/day within 14 days before initiation of the study drug 3) Patients who take mesalazine enemas or salazosulfapyrdine suppository within 14 days before initiation 4) 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. 5) Patients who are administered immune-suppressing drug before start of administration of clinical study drug within 90 day. 6) Patients who are treated by blood cell apheresis within 14 days before start of administration of clinical study drug. 7) Patients with history of drug hypersensitivity to mesalazine formulation and drugs of salicylic acid groups. 8) Patients with liver disease or kidney disease (Each clinician will judge the presence or absence of liver disease or kidney disease.) 9) Patients with serious cardiovascular disease, hemodyscrasia or lung disease, or patients with history of serious cardiovascular disease, hemodyscrasia or lung disease. 10) Patients with malignant tumor as complication.11) Pregnants, females who suckles, or females who wish to become pregnant. 12) Patients who are administered some kinds of clinical study drug within 6 months before obtaining informed consent. 13) Others, patients who are judged to be inadequate to participate in this trial by the principal investigator or co-investigator.

Related Information

• Primary Sponsor: Zeria Pharmaceutical Co.,LTD.
• Source(s) of Monetary Support: Zeria Pharmaceutical Co.,LTD.