Patients with ulcerative colitis in active phase
Conditions
Interventions
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 week
Sponsors
Zeria Pharmaceutical Co.,LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with ulcerative colitis at remission phase who are defined to show UC-DAI score of 3 or higher but 8 or less, and bloody stool score of 1 or higher. 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction degree of UC-DAI | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction degree of score of each UC-DAI item. Remission rate. Efficacy rate. | — |
Countries
Japan
Contacts
Public ContactZeria Pharmaceutical Co.,LTD.
Zeria Pharmaceutical Co.,LTD. Clinical Research
Outcome results
None listed