UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026570
Receipt No. R000028797
Scientific Title Evaluation of QOL in children with short stature after initiation of growth hormone therapy.
Date of disclosure of the study information 2017/03/15
Last modified on 2021/03/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of QOL in children with short stature after initiation of growth hormone therapy.
Acronym GT-QOL
Scientific Title Evaluation of QOL in children with short stature after initiation of growth hormone therapy.
Scientific Title:Acronym GT-QOL
Region
Japan

Condition
Condition small stature caused by growth hormone deficiency, Turner syndrome, or small for gestational age
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the change in QOL of children with small stature after initiation of growth hormone therapy using a questionnaire.
Basic objectives2 Others
Basic objectives -Others QOL of patients.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of QOL after 6 months and 12 months of growth hormone therapy compared with pretreatment.
Key secondary outcomes -Comparison of QOL of patients with that of normal children.
-Comparison of QOL measured by parents with that by patients themselves who are supposed to be able to answer the questionnaire.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Children with short stature caused by
-growth hormone deficiency
-Turner syndrome
-small for gestational age
whose epiphyseal growth plates remain unclosed.

-Never received growth hormone therapy before.
-Written informed consent.
Key exclusion criteria -Contraindication for Growject
-Patients (or parents) who are not supposed to be able to answer the questionnaire appropriately.
-Judgement of physicians.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shinobu
Middle name
Last name Ida
Organization Osaka Women's and Children's Hospital
Division name Department of Pediatric Gastroenterol
Zip code 594-1101
Address 840 Murodo-cho, Izumi, Osaka, 594-1101, Japan
TEL 0725-56-1220
Email idas@mch.pref.osaka.jp

Public contact
Name of contact person
1st name Shinobu
Middle name
Last name Ida
Organization Osaka Women's and Children's Hospital
Division name Department of Pediatric Gastroenterol
Zip code 594-1101
Address 840 Murodo-cho, Izumi, Osaka, 594-1101, Japan
TEL 0725-56-1220
Homepage URL
Email idas@mch.pref.osaka.jp

Sponsor
Institute JCR pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization JCR pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization IRB of Osaka Women's and Children's Hospital
Address 840 Murodo-cho, Izumi, Osaka, 594-1101, Japan
Tel 0725-56-1220
Email idas@mch.pref.osaka.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 03 Month 15 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 117
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason in preparation for publication
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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 02 Day
Date of IRB
2016 Year 08 Month 31 Day
Anticipated trial start date
2016 Year 11 Month 18 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 06 Month 19 Day

Other
Other related information To evaluate the change in QOL of children with small stature after initiation of growth hormone therapy using a questionnaire.

Management information
Registered date
2017 Year 03 Month 15 Day
Last modified on
2021 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028797

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.