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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018226
Receipt No. 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

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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
Institute Senju Pharmaceutical co.,ltd.
Institute
Department

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
URL(English) https://upload.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


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