UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018226
Receipt number R000021096
Scientific Title Phase III study of Efficacy, Safety and Pharmacokinetics of SJP-0129 in the Treatment for Patent Ductus Arteriosus
Date of disclosure of the study information 2015/07/31
Last modified on 2016/07/28 09:34:30

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Basic information

Public title

Phase III study of Efficacy, Safety and Pharmacokinetics of SJP-0129 in the Treatment for Patent Ductus Arteriosus

Acronym

Efficacy, Safety and Pharmacokinetics of SJP-0129 for Patent Ductus Arteriosus

Scientific Title

Phase III study of Efficacy, Safety and Pharmacokinetics of SJP-0129 in the Treatment for Patent Ductus Arteriosus

Scientific Title:Acronym

Efficacy, Safety and Pharmacokinetics of SJP-0129 for Patent Ductus Arteriosus

Region

Japan


Condition

Condition

Patent Ductus Arteriosus

Classification by specialty

Cardiology Pediatrics Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to determine the efficacy, safety and pharmacokinetics of treatment with intravenous SJP-0129 for Patent Ductus Arteriosus.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The proportion of infants that required rescue treatment on or prior to Study Day 14.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

SJP-0129 is given by 3 times at 24 intervals with intravenous injection.

Interventions/Control_2


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

1) Subjects with a birth weight of 500 to 1,500 grams, up to 32 weeks gestational age.
2) Less than 72 hours of age at the time of administration of SJP-0129.
3) One of the eldest infant in the case of multiple births. If he/she does not meet the eligibility criteria, the second infant will be included.
4) Written informed consent by legal representative.

Key exclusion criteria

1) Any major congenital malformations.
2) Any hyperbilirubinemia.
3) Less than 0.6 mL/kg/hr of baseline urinary output.
4) Any bleeding tendency from puncture sites.
5) Subjects with complicated with coagulation disorder.
6) Subjects with complicated with intraventricular hemorrhage.
7) Subjects with thrombopenia.
8) Subjects with suspected necrotizing enterocolitis.
9) Any major congenital malformations and/or chromosomal anomalies.
10) Any severe congenital bacterial infection.
11) Use of maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure < 72 hours prior to delivery.
12) Treatment with steroid or NSAID therapy since birth.
13) Subject with unremitting shock requiring very high doses of vasopressors.
14) Subjects with expected survival less than 48 hours.
15) Participation in any other clinical study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinya Hirano

Organization

Osaka Medical Center and Research Institute for Matemal and Child Health

Division name

Department of Neonatal Medicine

Zip code


Address

840, Murodocho, Izumi, Osaka, Japan

TEL

0725-56-1220

Email

hiranos@snow.odn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shogo Sameshima

Organization

Senju Pharmaceutical co.,ltd.

Division name

Regulatory Affairs & Medical Writing, Clinical Development

Zip code


Address

2-5-8, Hirano-machi, Chuo-ku, Osaka, Japan

TEL

06-6201-9605

Homepage URL


Email

shogo-sameshima@senju.co.jp


Sponsor or person

Institute

Senju Pharmaceutical co.,ltd.

Institute

Department

Personal name



Funding Source

Organization

Senju Pharmaceutical 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


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

2015 Year 07 Month 31 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

2015 Year 06 Month 24 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 07 Day

Last modified on

2016 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name