UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012620 |
|---|---|
| Receipt number | R000014652 |
| Scientific Title | Continuous subcutaneous injection of octreotide for congtenital hyperinsulinism: efficacy and safety. |
| Date of disclosure of the study information | 2013/12/19 |
| Last modified on | 2019/07/21 17:54:46 |
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Basic information
Public title
Continuous subcutaneous injection of octreotide for congtenital hyperinsulinism: efficacy and safety.
Acronym
Subcutaneous continuous octreotide for congenital hyperinsulinism (SCORCH study)
Scientific Title
Continuous subcutaneous injection of octreotide for congtenital hyperinsulinism: efficacy and safety.
Scientific Title:Acronym
Subcutaneous continuous octreotide for congenital hyperinsulinism (SCORCH study)
Region
| Japan |
Condition
Condition
congenital hyperinsulinism
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the efficacy and safety of continuous subcutaneous octreotide injection for congenital hyperinsulinism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short term increase in blood glucose comparing the mean blood glucose before 24 hours and after 48 hours of the initiation of the treatment.
Key secondary outcomes
1) Long-term reduction in the amount of glucose infusion to maintain blood glucose at 1 week, 2 weeks, 4 weeks, and at every 3 month after 5 weeks.
2) Neurological outcome after > 1 year of the initiation of the treatment.
3) Number of ypoglycemic episodes < 45 mg/dL during the treatment, categorized as asymptomatic, symptomatic, or severe.
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
After stabilizing the blood glucse by continuous high concentration glucose infusion, continuous subcutaneous octreotide injection is initiated at a dose of up to 25 micrograms/kg/day with continuous monitoring of blood glucose for the first 48 hours
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
Patients who meet all criteria below.
1 Age between 2 weeks to 1 year and with congenital hyperinsulinemic hypoglycemia (insulin > 3 microunits/mL at blood glucose <45 mg/dL)
2 Requires continuous glucose infusion at > 6 mg/kg/min to maintain blood glucose > 60 mg/dL.
3 Inability to maintain blood glucose > 60 mg/dL with diazoxide at15 mg/kg/d.
4 Consent to participate in the study from the guardians.
5 Consent to undergo molecular testing for congenital hyperinsulinism.
Key exclusion criteria
1) Hypoglycemic patients with causes other than hyperinsulinemia.
2) Patients with severe extrapancreatic comorbidities.
a. intestinal dysfunction
b. respiratory failure
c. severe liver dysfunction with transaminases or bilirubin > 3x ULN for age.
d. renal failure with urea nitrogen or creatinine > 3x ULN for age.
e. patient with other comorbidities who would not be appropriate for enrollment.
Target sample size
7
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
t-yorifuji@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
Pediatric Endocrinology and Metabolism
Zip code
Address
2-13-22 Miyakojima-Hondori, Miyakojima, Osaka 534-0021
TEL
06-6929-1221
Homepage URL
scorch-study@med.osakacity-hp.or.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development. Research group for the study 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
Other related organizations
Co-sponsor
Japanese Society for Pediatric Endocrinology
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
大阪市立総合医療センター（大阪府）、聖マリアンナ医科大学病院（神奈川県）、北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/64/9/64_EJ17-0024/_article/-char/en
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
Main results already published
Date of protocol fixation
| 2013 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 19 | Day |
Last modified on
| 2019 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014652
