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


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 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


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

Value
https://center6.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