UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000410 |
|---|---|
| Receipt number | R000000500 |
| Scientific Title | A phase III, efficacy and safety study of phenobarbital sodium injection in newborns with neonatal convulsion |
| Date of disclosure of the study information | 2006/04/26 |
| Last modified on | 2008/02/29 08:56:15 |
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Basic information
Public title
A phase III, efficacy and safety study of phenobarbital sodium injection in newborns with neonatal convulsion
Acronym
JNR-NP
Scientific Title
A phase III, efficacy and safety study of phenobarbital sodium injection in newborns with neonatal convulsion
Scientific Title:Acronym
JNR-NP
Region
| Japan |
Condition
Condition
neonatal convulsion
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of phenobarbital sodium injection in newborns with neonatal convulsion, and to evaluate the relationship between its blood concentration and efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Rate of "excellent" cases
Excellent : disapperance of convulsion
Effective : improvement of degree or frequency of symptom
Poor : no improvement
Change in degree or frequency of convulsion 30 min. after administration
Key secondary outcomes
*Consistency of assessment between committee and investigator
*Change in degree or frequency of convulsion 60 min. after administration
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
phenobarbital sodium 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
| 4 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with abnormal movement suspected neonatal convulsion
2) Patients with asphyxia neonatorum (Apgar score of less than 5 at five minutes with a base deficit of more than 10 mmol/L)
3) Patients with traumatic delivery
4) Patients with central nerve system infection or malformation
5) Patients with abnormal movement by hypoglycemia or electrolyte abnormality
Key exclusion criteria
1) Patients with hypersensitivity to Phenobarbital or Barbituric compounds
2) Patients with acute intermittent porphyria
3) Patients after anticonvulsant or Barbituric preparation therapy
4) Patients with any trauma except birth injury
5) Patients with therapeutic hypothermia of brain
6) Patients participated to other clinical trials
7) Patients judged as inappropriate to participate in this study by investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Itoh |
Organization
Kagawa University, University Hospital
Division name
Department of Pediatrics
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan
TEL
087-898-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Department of Pediatrics
Division name
Clinical study organizer
Zip code
Address
TEL
087-898-5111
Homepage URL
Sponsor or person
Institute
Kagawa University, University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka MCRI for MCH,Kanagawa CMC,Kumamoto Municipal Hospital of Kumamoto City,NCCHD,Showa University Hospital,The University of Tokyo Hospital,NHO Okayama Medical Center
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
| 2006 | Year | 04 | Month | 26 | 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
| 2005 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 04 | Month | 26 | Day |
Last modified on
| 2008 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000500
