臨床研究等提出・公開システム

Date of registration	July. 03, 2018
Last modified on	Mar. 25, 2020
Trial ID	jRCT2080223964

Scientific Title	Clinical Pharmacology Study of TS-071 in Paediatric Patients with Type 2 Diabetes Mellitus
Public Title	Clinical Pharmacology Study of TS-071 in Paediatric Patients with Type 2 Diabetes Mellitus

Completion Date or Terminated date	Sept. 24, 2019
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Taisho Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@taisho.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Taisho Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@taisho.co.jp

Recruitment Status	completed

Date of First Enrolment		Aug. 06, 2018
Target Sample Size		18
Study Type		Interventional
Study Design	Study Design	Open-label
Study Design	Objective	treatment purpose
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	- Type 2 diabetes mellitus - HbA1c 6.5% to 10.5% etc.
	Exclusion Criteria	- Diabetes mellitus other than type 2 - Fasting plasma glucose exceeding 250 mg/dL at the screening test - Concurrent urinary tract infection or genital infection, or a history of repeated occurrences of such infection etc.
	Minimum Age	9age old over
	Maximum Age	17age old under
	Gender	Both
Health Condition or Problem Studied		Type 2 diabetes mellitus
Intervention(s)		investigational material(s) Generic name etc : TS-071 INN of investigational material : Luseogliflozin hydrate Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety pharmacokinetics pharmacodynamics Pharmacokinetics, pharmacodynamics, and safety
Secondary Outcome		other -

Primary Sponsor	Taisho Pharmaceutical co., LTD
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Pediatric Clinical Trials Network Central Institutional Review Board
Address of IRB	2-10-1 Okura, Setagaya-Ku, Tokyo, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Oct. 16, 2018

Secondary ID No.	JapicCTI-184022
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
8	Mar. 25, 2020	(this page)	Changes
7	Sept. 27, 2019	Detail	Changes
6	April. 05, 2019	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	Nov. 30, 2018	Detail	Changes
3	Nov. 30, 2018	Detail	Changes
2	July. 03, 2018	Detail	Changes
1	July. 03, 2018	Detail

List of change history