UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000752 |
|---|---|
| Receipt number | 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 15:37:32 |
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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
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
murakami@ltt.co.jp
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000903
