UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021109 |
|---|---|
| Receipt number | R000024356 |
| Scientific Title | Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer |
| Date of disclosure of the study information | 2016/02/19 |
| Last modified on | 2019/08/22 20:47:50 |
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Basic information
Public title
Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer
Acronym
Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer (Sivelestat trial)
Scientific Title
Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer
Scientific Title:Acronym
Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer (Sivelestat trial)
Region
| Japan |
Condition
Condition
idiopathic interstitial pneumonia (IIP)
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the preventive effect of Sivelestat on postoperative acute exacerbation of IIP in patients suffering from lung cancer combined wiyh IIP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
acute exacerbation of IIP within 30 postoperative days
Key secondary outcomes
30 postoperative day survival rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Control (n=30): intra- and postoperative management without Sivelestat
Interventions/Control_2
Trial (n=30): 7days administration of Sivelestat 0.2microgram/kgBW/hr div started from surgical operation
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
| 25 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Untreated patients with non-small-cell lung cancer who have plan of sergical treatment
(2) Patients with IIP which shows ground-glass opacity or reticular pattern in both lungs on preoperative HR-CT
Key exclusion criteria
(1) With serious liver disorder
(2) With serious renal dysfunction
(3) With bleeding tentency
(4) Patients registered in clinical trial of other drugs
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Chida |
Organization
Dokkyo medical university
Division name
Department of general thoracic surgery
Zip code
Address
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi, JAPAN
TEL
0282-86-1111
chida-ths@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sumiko Maeda |
Organization
Dokkyo medical university
Division name
Department of general thoracic surgery
Zip code
Address
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi, JAPAN
TEL
0282-87-2160
Homepage URL
sumaeda@dokkyomed.ac.jp
Sponsor or person
Institute
Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
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
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
| 2016 | Year | 02 | Month | 19 | 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
| 2012 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2019 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024356
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| Registered date | File name |
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| Registered date | File name |
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