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


Email



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


Email



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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name