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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011356
Receipt No. 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

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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
Email 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/
Email scorch-registry@med.osakacity-hp.or.jp

Sponsor
Institute The Specified Disease Treatment Research Program on Efficacy and safety of subcutaneous continuous octreotide infusion for congenital hyperinsulinism.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013254

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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