Patients with ulcerative colitis in remission phase.
Conditions
Interventions
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
Sponsors
Zeria Pharmaceutical Co.,LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with ulcerative colitis in remission phase who are defined to show Ulcerative Colitis-Disease Activity Index (UC-DAI) score of not less than 2 and bloody stool score of 0. 2) Subjects whose age is 16 years or older but less than 65 years old at the time of obtaining informed consent (no restriction for sex) 3) Patients who can understand the contents of this clinical trial, and from whom informed consent to participate in this trial is obtained in written form. In a case of patients under age (less than 20 years old) atthe acquisition time of the informed consent, a consent form can be obtained a representative of the patients.
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-incidence of bloody stool | — |
Secondary
| Measure | Time frame |
|---|---|
| Period of non-emergence of bloody stool. Non-recurrence rates. Period of non-recurrence of bloody stool, and change of UC-DAI. | — |
Countries
Japan
Contacts
Public ContactZeria Pharmaceutical Co.,LTD.
Zeria Pharmaceutical Co.,LTD. Clinical Resarch
Outcome results
None listed