Early Phase II clinical trial of PC-SOD -Study of the efficacy and safety of PC-SOD in patients with ulcerative colitis-

UMIN ID: UMIN000000753

Registered date:27/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Ulcerative colitis(UC-DAI:more than 4)
• Date of first enrollment: 2005/05/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 80mg 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.

Outcome(s)

• Primary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: LTT Bio-Pharma Co.,Ltd.
• Source(s) of Monetary Support: LTT Bio-Pharma Co.,Ltd.