UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011356 |
|---|---|
| Receipt number | R000013254 |
| Scientific Title | A registry study to analyze the efficacy and safety of subcutaneous octreotide injection for congenital hyperinsulinism |
| Date of disclosure of the study information | 2013/08/05 |
| Last modified on | 2017/02/15 01:36:07 |
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Basic information
Public title
A registry study to analyze the efficacy and safety of subcutaneous octreotide injection for congenital hyperinsulinism
Acronym
A registry study to analyze the efficacy and safety of subcutaneous octreotide injection for congenital hyperinsulinism
Scientific Title
A registry study to analyze the efficacy and safety of subcutaneous octreotide injection for congenital hyperinsulinism
Scientific Title:Acronym
A registry study to analyze the efficacy and safety of subcutaneous octreotide injection for congenital hyperinsulinism
Region
| Japan |
Condition
Condition
Congenital hyperinsulinism
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of subcutaneous octreotide injection for congenital hyperinsulinism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction in glucose infusion rate to keep euglycaemia at 4 weeks after initiation of the treatment. Effective as defined by the reduction of glucose infusion to less than 8.64 g/kg/d. Remarkably effective as defined by the cessation of glucose infusion.
Key secondary outcomes
(1) Reduction in glucose infusion rate at other time points.
(2) Neurological outcome at 1 year after initiation of the treatment. Normal as defined by the developmental quotient (DQ) > 70, delay as defined by DQ < 69.
(3) Safety profile as assessed by body measurements, adverse events, laboratory tests, and abdominal ultrasound.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 2 | weeks-old | <= |
Age-upper limit
| 52 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with diazoxide-unresponsive congenital hyperinsulinism treated by subcutaneous octreotide injection.
(2) Patients whose guardians gave an informed consent to participate in the study.
Key exclusion criteria
None
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Yorifuji |
Organization
Osaka City General Hospital
Division name
Pediatric Endocrinology and Metabolism
Zip code
Address
2-13-22 Miyakojima-Hondori, Miyakojima, Osaka 534-0021
TEL
06-6929-1221
scorch-registry@med.osakacity-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Yorifuji |
Organization
Osaka City General Hospital
Division name
Clinical Research Center
Zip code
Address
2-13-22 Miyakojima-Hondori, Miyakojima, Osaka 534-0021
TEL
06-6929-1221
Homepage URL
http://byouin-city-osaka.jp/
scorch-registry@med.osakacity-hp.or.jp
Sponsor or person
Institute
The Specified Disease Treatment Research Program on Efficacy and safety of subcutaneous continuous octreotide infusion for congenital hyperinsulinism.
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Japanese Society for Pediatric Endocrinology
Name of secondary funder(s)
None
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
大阪市立総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 05 | 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
| 2013 | Year | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 27 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 27 | Day |
Other
Other related information
A registry study to accumulate the clinical data of patients who developed diazoxide-unresponsive congenital hyperinsulinism at 2 weeks - one year of age and were treated with subcutaneous- or continuous subcutaneous octreotide injection. The aim of the study is to analyze the efficacy and safety of octreotide treatment for congenital hyperinsulinism. Data are to be collected at intervals from the onset of the treatment until either the end of the treatment or one year after initiation of the treatment. A follow up survey is also scheduled. The following data are to be collected. Patient background, laboratory findings at diagnosis, details of octreotide treatment, additional treatment for hypoglycemia, other medications, adverse events, growth measurements, and laboratory results including complete blood counts, blood chemicals (glucose, electrolytes, AST, ALT, total bilirubin, direct bilirubin, urea nitrogen, creatinine, total protein, albumin), self-measured blood glucose, developmental quotient, and abdominal ultrasound.
Management information
Registered date
| 2013 | Year | 08 | Month | 02 | Day |
Last modified on
| 2017 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013254
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
