Unique ID issued by UMIN | UMIN000041833 |
---|---|
Receipt number | R000047755 |
Scientific Title | Effect of low-irritant formulation on adherence to growth hormone therapy in pediatric patients with short statue: An exploratory retrospective observational study. |
Date of disclosure of the study information | 2020/09/18 |
Last modified on | 2021/09/22 12:46:33 |
Effect of low-irritant formulation on adherence to growth hormone therapy in pediatric patients with short statue: An exploratory retrospective observational study.
GTL-Adherence
Effect of low-irritant formulation on adherence to growth hormone therapy in pediatric patients with short statue: An exploratory retrospective observational study.
GTL-Adherence
Japan |
Short statue caused by growth hormone deficiency, Turner syndrome, or SGA (born small for gestational age)
Endocrinology and Metabolism | Pediatrics |
Others
NO
-To retrospectively investigate automatically recorded medication adherence of pediatric patients receiving GH therapy through electronic injector Growjector-L.
-To evaluate effect of low-irritant new formulation of GH (Growject) on medication adherence in comparison with old one.
Others
-To explore factors associated with low adherence to GH therapy.
Exploratory
Pragmatic
Not applicable
Medication adherence of patients administered new or old formulation of Growject in daily clinical practice.
-Patients characteristics.
-Time course change in medication adherence.
-Nonadherence-free survival.
-Exploration on factors affecting adherence to GH therapy.
Observational
3 | years-old | <= |
Not applicable |
Male and Female
-Treatment-naive at the start of GH therapy.
-Aged 3 years or older at the start of GH therapy.
-Using Growjector-L.
-Started GH therapy between September 1, 2017 and January 31, 2021.
-Written informed consent from a legally acceptable representative of the patient, along with informed assent if applicable.
-Contraindications for GH therapy.
eg, Diabetes, malignancy, (possible) pregnancy.
-Judgement of physicians.
50
1st name | Kenichi |
Middle name | |
Last name | Kashimada |
Tokyo Medical and Dental University
Department of Pediatrics and Developmental Biology
113-8510
1-5-45, Yushima, Bunkyo-ku, 1138510, Tokyo
03-3813-6111
kkashimada.ped@tmd.ac.jp
1st name | Kei |
Middle name | |
Last name | Takasawa |
Tokyo Medical and Dental University
Department of Pediatrics and Developmental Biology
113-8510
1-5-45, Yushima, Bunkyo-ku, 1138510, Tokyo
03-3813-6111
ktakasawa.ped@tmd.ac.jp
Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University
JCR pharmaceuticals Co., Ltd.
Profit organization
Japan
Life Science and Bioethics Research Center, Tokyo Medical and Dental University
1-5-45, Yushima, Bunkyo-ku, 1138510, Tokyo
03-3813-6111
info.bec@tmd.ac.jp
NO
東京医科歯科大学医学部附属病院をはじめとする全国約10施設
2020 | Year | 09 | Month | 18 | Day |
Unpublished
41
No longer recruiting
2020 | Year | 08 | Month | 17 | Day |
2020 | Year | 08 | Month | 17 | Day |
2020 | Year | 09 | Month | 01 | Day |
2021 | Year | 05 | Month | 31 | Day |
To retrospectively analyze medication adherence data automatically recorded in electronic GH injector Growjector-L.
2020 | Year | 09 | Month | 18 | Day |
2021 | Year | 09 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047755
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |