NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000300

Registered date:22/12/2005

Z-206 Phase III Clinical Trial - Investigation on the remission-inducing effect in patients with Crohn's disease in active phase -

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients with Crohn's disease in active phase
Date of first enrollment2005/12/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. Placebo group:Three tablets of Z-206 placebo tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks.

Outcome(s)

Primary OutcomeRemission induction rate Degree of decrease in CDAI QOL (IBDQ)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum64years-old
GenderMale and Female
Include criteria1)Patients whose Crohn's Disease Activity Index (CDAI) is not less than 150 but less than 250 are defined to be in active phase. 2)Patients whose lesion is mainly observed in the end of ileum or lower part. 3) Outpatients with age of 16 or older and 64 or younger at the time of obtaining informed consents (however, no restriction on sex). 4) Patients who understand the substances of this clinical trial and can give consent to participate in this clinical trial in writing. In a case of a patient with age below 20 at the time of obtaining informed consent, a patient for whom consent can be obtained from his or her custodian.
Exclude criteria1)Patients to whom oral formulation of mesalazine of a dose exceeding 3 g/day was administered or oral formulation of salazosulfapyridine of a dose exceeding 6 g/day was administered within 7 days of the start of administration of this trial drug. 2)Patients to whom mesalazine enema or salazosulfapyridine suppository was given within 7 days of the start of administration of this clinical study drug. 3)Patients who took adrenal cortex hormone within 14 days before start of administration of clinical study drug. 4)Patients who were given metronidazole or ciprofloxacin within 14 days before start of administration of clinical study drug. 5)Patients who were administered immune-suppressing drugs within 90 days before start of administration of clinical study drug. 6)Patients who were administered infliximab (anti-human TNF-alpha monoclonal antibody) within 90 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 history of enterectomy for Crohn's disease. 9)Patients with active anal lesion (Patients with anal stenosis that affect number of defecation, or patients with anal fistula accompanied by fever) 10)Patients treated by total parenteral nutrition method. 11)Patients with liver disease or kidney disease (Each clinician will judge the presence or absence of liver disease or kidney disease). 12)Patients with serious cardiovascular disease, hemodyscrasia or lung disease, or patients with history of serious cardiovascular disease, hemodyscrasia, lung disease. 13)Patients with malignant tumors 14)Patients who are pregnant, breast-feeding or desire to become pregnant during this trial period 15)Patients who were administered some kinds of clinical study drug within 6 months before obtaining informed consent. 16)Patients whom principle investigator or co-investigator judged unfit to participate in this trial.

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