UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008862 |
|---|---|
| Receipt number | R000010377 |
| Scientific Title | A clinical study of the usefulness of a neutrophil elastase inhibitor in patients with postoperative acute exacerbation of interstitial pneumonia complicated with lung cancer |
| Date of disclosure of the study information | 2012/09/10 |
| Last modified on | 2016/03/17 11:06:18 |
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Basic information
Public title
A clinical study of the usefulness of a neutrophil elastase inhibitor in patients with postoperative acute exacerbation of interstitial pneumonia complicated with lung cancer
Acronym
A clinical study of the usefulness of a neutrophil elastase inhibitor in patients with postoperative acute exacerbation of interstitial pneumonia complicated with lung cancer
Scientific Title
A clinical study of the usefulness of a neutrophil elastase inhibitor in patients with postoperative acute exacerbation of interstitial pneumonia complicated with lung cancer
Scientific Title:Acronym
A clinical study of the usefulness of a neutrophil elastase inhibitor in patients with postoperative acute exacerbation of interstitial pneumonia complicated with lung cancer
Region
| Japan |
Condition
Condition
Interstitial pneumonia combine with lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine if a neutrophil elastase inhibitor (sivelestat sodium) can prevent postoperative acute exacerbation of interstitial pneumonia complicated with lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence or absence of postoperative acute exacerbation
Key secondary outcomes
PaO2/FIO2,Laboratory values(KL-6,SP-A,SP-D,LDH,CRP)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sivelestat sodium treatment group
Interventions/Control_2
Non-sivelestat sodium treatment group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with image findings of interstitial pneumonia who are scheduled for surgery for primary lung cancer
Key exclusion criteria
1) Patients with a history of sensitivity to sivelestat sodium
2) Patients judged inappropriate by attending physicians
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Suzuki |
Organization
Juntendo University School of Medicine
Division name
General Thoracic Surgery
Zip code
Address
1-3, Hongo 3 chome, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Takamochi |
Organization
Juntendo University School of Medicine
Division name
General Thoracic Surgery
Zip code
Address
1-3, Hongo 3 chome, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Department of Thoracic Surgery Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2012 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2009 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 06 | Day |
Last modified on
| 2016 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010377
