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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000752
Receipt No. R000000903
Scientific Title Phase II double blind trial of PC-SOD in patients with idiopathic interstitial pneumonias
Date of disclosure of the study information 2007/06/27
Last modified on 2011/11/22

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Basic information
Public title Phase II double blind trial of PC-SOD in patients with idiopathic interstitial pneumonias
Acronym Dose finding trial of PC-SOD for idiopathic interstitial pneumonias
Scientific Title Phase II double blind trial of PC-SOD in patients with idiopathic interstitial pneumonias
Scientific Title:Acronym Dose finding trial of PC-SOD for idiopathic interstitial pneumonias
Region
Japan

Condition
Condition Idiopathic interstitial pneumonias(GradeIII to IV)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

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

Assessment
Primary outcomes Forced Vital Capacity(FVC)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
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 28 days.
Interventions/Control_2 Intravenous infusion of 80mg of PC-SOD(lecithinized superoxide dismutase) is administered over 1 hour once a day for consecutive 28 days.
Interventions/Control_3 Intravenous infusion of placebo of PC-SOD(lecithinized superoxide dismutase) is administered over 1 hour once a day for consecutive 28 days.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients confirmed idiopathic interstitial pneumonias by X-ray and HRCT
2)Patients with Grade III to Grade IV idiopathic interstitial pneumonias and possible measurement of vital capacity
3)Patients must be in hospital during the period of the clinical trial.
After the trial, they will be consulted in hospital or as outpatients.
4)Patients who personally give informed consent in writing
Key exclusion criteria 1)Exclusion criteria with respect to relative diseases
(1)Patients with interstitial pneumonia caused by medicine
(2)Patients who have complicated asthma or COPD
(3)Patients who have complicated infectious disease of lung(respiratory organs) which affects the effect of the drug
2)Exclusion criteria with respect to prior treatment
(1)Patients who initiated steroid administration or changed the usage and dosage of it within four weeks prior to the investigational new drug
(2)Patients who initiated administration of immunosuppressive drugs(ciclosporin, tacrolimus hydrate, azathioprine, cyclophosphamide, methotrexate)
3)Exclusion criteria with respect to safety
(1)Patients with disease of kidney, liver, digestive organs(more than middle class)
(2)Patients with severe blood disease or circulatory organ disease
(3)Patients with the past or complication of neoplasms such as cancers or tumors
(4)Patients who are pregnant or have possibility of pregnancy and are under breast-feeding
(5)Patients who attended any other clinical trial within four months prior to this trial
(6)Patients who have the history of allergic reactions against protein drugs
(7)Patients with hypotonic dehydration
(8)Patients who, in the opinion of the principal investigators or investigators, are not likely to participate in the trial
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Kudo
Organization Nippon Medical School
Division name Department of Pulmonary Medicine/Infection and Oncology
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo113-8602, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Murakami
Organization LTT Bio-Pharma Co.,Ltd.
Division name Department of Clinical Development
Zip code
Address Shiodome Building 3F 1-2-20 Kaigan, Minato-ku, Tokyo 105-0022 Japan
TEL 03-5733-7394
Homepage URL http://www.ltt.co.jp
Email murakami@ltt.co.jp

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 Partially published

Result
URL related to results and publications http://www.ltt.co.jp
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
2007 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 03 Month 01 Day
Date trial data considered complete
2008 Year 03 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
2011 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000903

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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