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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000753
Receipt No. R000000904
Scientific Title Early Phase II clinical trial of PC-SOD -Study of the efficacy and safety of PC-SOD in patients with ulcerative colitis-
Date of disclosure of the study information 2007/06/27
Last modified on 2008/06/27

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Basic information
Public title Early Phase II clinical trial of PC-SOD
-Study of the efficacy and safety of PC-SOD in patients with ulcerative colitis-
Acronym Early phase II clinical trial of PC-SOD for ulcerative colitis
Scientific Title Early Phase II clinical trial of PC-SOD
-Study of the efficacy and safety of PC-SOD in patients with ulcerative colitis-
Scientific Title:Acronym Early phase II clinical trial of PC-SOD for ulcerative colitis
Region
Japan

Condition
Condition Ulcerative colitis(UC-DAI:more than 4)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This multicenter non-blind trial aims to evaluate the efficacy and safety of daily dose of PC-SOD(40mg and 80mg) in patients with active ulcerative colitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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 secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key 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
Key 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
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshifumi Hibi
Organization Keio University Hospital
Division name Division of Gastroenterology, Department of Internal Medicine
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo160-8582, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization LTT Bio-Pharma Co.,Ltd.
Division name Department of Clinical Development
Zip code
Address Atago Green Hills MORI Tower 26F, 2-5-1, Atago, Minato-ku, Tokyo105-6201, Japan
TEL 03-5733-7391
Homepage URL
Email

Sponsor
Institute LTT Bio-Pharma Co.,Ltd.
Institute
Department

Funding Source
Organization LTT Bio-Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 06 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2005 Year 05 Month 01 Day
Last follow-up date
2007 Year 11 Month 01 Day
Date of closure to data entry
2008 Year 02 Month 01 Day
Date trial data considered complete
2008 Year 02 Month 01 Day
Date analysis concluded
2008 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 06 Month 27 Day
Last modified on
2008 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000904

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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