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

UMIN ID: C000000289

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 remission phase.
• Date of first enrollment: 2005/12/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Non-incidence of bloody stool
• Secondary Outcome: Period of non-emergence of bloody stool. Non-recurrence rates. Period of non-recurrence of bloody stool, and change of UC-DAI.

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude 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

Related Information

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