NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000289

Registered date:21/11/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients with ulcerative colitis in remission phase.
Date of first enrollment2005/12/01
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeNon-incidence of bloody stool
Secondary OutcomePeriod 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 minimum16years-old
Age maximum64years-old
GenderMale and Female
Include criteria1) 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.
Exclude criteria1)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

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 Resarch
scientific contact
Name Toshifumi Hibi
Address 35 Shinano-Machi,Shinjuku-ku,Tokyo 160-8582,Japan Japan
Telephone
E-mail
Affiliation Keio University School of Medicine Department of Internal Medicine