Ulcerative colitis(UC-DAI:more than 4)
Conditions
Interventions
Intravenous infusion of 40mg of PC-SOD(lecithinized superoxide dismutase) is administered over 1 hour once a day for consecutive 14 days followed by twice a week for 2 weeks.
Intravenous infusion of 8
Sponsors
LTT Bio-Pharma Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who agreed to be sent to hospitalization for the period of 2 weeks (2)Patients who personally give informed consent in writing. When patients are less than 20 years old, the written consents from their persons with parental authority(essential guardians) in addition to the patients'informed consents are needed. (3)Cases which were diagnosed as moderately active ulcerative colitis (4)Cases which were diagnosed as one attack only or relapse-remitting type
Exclusion criteria
Exclusion criteria: (1)Exclusion criteria with respect to efficacy 1)Patients who were diagnosed as rectitis type by spread of a pathological change (2)Exclusion criteria with respect to prior treatment 1)Patients who initiated steroid administration or remarkably changed the usage and dosage of it within 14 days prior to the investigational new drug 2)Patients who initiated administration of immunosuppressive drugs(azathioprine, mercaptopurine) 3)Patients who were treated with ciclosporin within 30 days prior to the administration of the investigational new drug 4)Patients who were treated with leukocyte removal therapy within 14 days prior to the administration of the investigational new drug (3)Exclusion criteria with respect to safety 1)Patients with renal damage (more than Grade 2) 2)Patients with liver damage 3)Patients who have complicated severe cardiovascular, respiratory, hematological diseases 4)Patients who have complicated neoplasms like cancers, tumors and so on 5)Patients who are pregnant or have possibility of pregnancy and under breast-feeding 6)Patients who attended any other clinical within four months prior to this trial 7)Patients who, in the opinion of the principal investigator or investigators are not likely to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Four items for UC-DAI: 1.stool frequency(0-3) 2.rectal bleeding(0-3) 3.mucosal appearance(0-3) 4.physician's global assessment(0-3) | — |
Countries
Japan
Outcome results
None listed