UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000753 |
|---|---|
| Receipt number | 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 10:09:57 |
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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
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
Sponsor or person
Institute
LTT Bio-Pharma Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000904
