Patients with Crohn's disease in remission phase
Conditions
Interventions
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 48 weeks.
Mesalazine group:Four tablets of
Sponsors
Zeria Pharmaceutical Co.,LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients whose Crohn's Disease Activity Index (CDAI) is less than 150 are defined to be in remission 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.
Exclusion criteria
Exclusion criteria: 1)Patients to whom mesalazine enema or salazosulfapyridine suppository was given within 7 days of the start of administration of this clinical study drug. 2)Patients who took adrenal cortex hormone within 14 days before start of administration of clinical study drug. 3)Patients who were given metronidazole or ciprofloxacin within 14 days before start of administration of clinical study drug. 4)Patients who were administered immune-suppressing drugs within 90 days before start of administration of clinical study drug. 5)Patients who were administered infliximab (anti-human TNF-alfha monoclonal antibody) within 90 days before start of administration of clinical study drug. 6)Patients with history of drug hypersensitivity to mesalazine formulation and drugs of salicylic acid groups. 7)Patients with history of enterectomy for Crohn's disease. 8)Patients with active anal lesion (Patients with anal stenosis that affect number of defecation, or patients with anal fistula accompanied by fever) 9)Patients treated by total parenteral nutrition method. 10)Patients with liver disease or kidney disease (Each clinician will judge the presence or absence of liver disease or kidney disease). 11)Patients with serious cardiovascular disease, hemodyscrasia or lung disease, or patients with history of serious cardiovascular disease, hemodyscrasia, lung disease. 12)Patients with malignant tumors 13)Patients who are pregnant, breast-feeding or desire to become pregnant during this trial period 14)Patients who were administered some kinds of clinical study drug within 6 months before obtaining informed consent. 15)Patients whom principle investigator or co-investigator judged unfit to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate Remission maintenance period QOL (IBDQ) | — |
Countries
Japan
Contacts
Public ContactZeria Pharmaceutical Co.,LTD.
Zeria Pharmaceutical Co.,LTD. Clinical Research
Outcome results
None listed