UMIN-CTR Clinical Trial

Basic information
Public title	A questionnaire survey of growth hormone supplemental therapy
Acronym	Questionnaire growth hormone therapy
Scientific Title	A questionnaire survey of growth hormone supplemental therapy
Scientific Title:Acronym	Questionnaire growth hormone therapy
Region	Japan

Condition
Condition	short stature
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	I disclose reason for encouter, problem of explanation check and therapy induction for short stature. I can make use of my experiences there for future developments in therapy for short stature.
Basic objectives2	Others
Basic objectives -Others	Patients and their families enforcing growth hormone replacement therapy now
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire collection and analysis
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	3 years-old <
Age-upper limit	20 years-old >
Gender	Male and Female
Key inclusion criteria	The person that it was obtained consent for questionary survey among the patients who continued growth hormone replacement therapy in our hospital
Key exclusion criteria	The person that it was not obtained consent for questionary survey
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Kikuchi
Organization	Haga red cross hospital
Division name	department of pediatrics
Zip code	321-4308
Address	Moka city, Daimachi 2461, Tochigi pref.
TEL	0285822195
Email	y.kikuchi@haga.jrc.or.jp

Public contact
Name of contact person	1st name Yutaka Middle name Last name Kikuchi
Organization	Haga red cross hospital
Division name	department of pediatrics
Zip code	321-4308
Address	Moka city, Daimachi 2461, Tochigi pref.
TEL	0285822195
Homepage URL
Email	y.kikuchi@haga.jrc.or.jp

Sponsor
Institute	Haga red cross hospital
Institute
Department

Funding Source
Organization	Haga red cross hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	haga redcross hospital
Address	Nakago 271, Moka-city, Tochigi-pref.
Tel	0285-82-2195
Email	y.kikuchi@haga.jrc.or.jp

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	2017 Year 02 Month 20 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	2017 Year 01 Month 13 Day
Date of IRB	2016 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2019 Year 08 Month 17 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 08 Month 17 Day
Date analysis concluded	2020 Year 03 Month 01 Day

Other
Other related information	There is no special findings.

Management information
Registered date	2017 Year 02 Month 13 Day
Last modified on	2020 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030008