NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000288

Registered date:21/11/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients with ulcerative colitis in active phase
Date of first enrollment2005/12/01
Target sample size210
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeReduction degree of UC-DAI
Secondary OutcomeReduction degree of score of each UC-DAI item. Remission rate. Efficacy rate.

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum64years-old
GenderMale and Female
Include criteria1)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.
Exclude criteria1)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

Contact

public contact
Name Zeria Pharmaceutical Co.,LTD.
Address 10-11,Nihonbashi,Kobuna-cho,Chuo-ku,Tokyo,103-8351,Japan Japan
Telephone
E-mail kaihatu@zeria.co.jp
Affiliation Zeria Pharmaceutical Co.,LTD. Clinical Research
scientific contact
Name Toshifumi Hibi
Address 35 Shinano-Machi,Shinjuku-ku,Tokyo 160-8582,Japan Japan
Telephone 03-3353-1211
E-mail
Affiliation Keio University School of Medicine Department of Internal Medicine