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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000021109
Date of registration:	19/02/2016
Prospective Registration:	No
Primary sponsor:	Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Public title:	Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer
Scientific title:	Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer - Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer (Sivelestat trial)
Date of first enrolment:	2013/10/21
Target sample size:	120
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024356
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Phase III

Countries of recruitment
Japan

Contacts

Name:	Sumiko Maeda
Address:	880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi, JAPAN Japan
Telephone:	0282-87-2160
Email:	sumaeda@dokkyomed.ac.jp
Affiliation:	Dokkyo medical university Department of general thoracic surgery

Name:	Masayuki Chida
Address:	880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi, JAPAN Japan
Telephone:	0282-86-1111
Email:	chida-ths@umin.ac.jp
Affiliation:	Dokkyo medical university Department of general thoracic surgery

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 25years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

idiopathic interstitial pneumonia (IIP)

Intervention(s)

Control (n=30): intra- and postoperative management without Sivelestat
Trial (n=30): 7days administration of Sivelestat 0.2microgram/kgBW/hr div started from surgical operation

Primary Outcome(s)

acute exacerbation of IIP within 30 postoperative days

Secondary Outcome(s)

30 postoperative day survival rate

Secondary ID(s)

Source(s) of Monetary Support

None

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 08/06/2013
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	07/03/2020
URL:

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