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

Email

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


Email

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


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)、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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name