臨床研究等提出・公開システム

Date of registration	Dec. 17, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221982

Scientific Title	Early phase II study of TAC-401 in H. pylori-positive subjects. -Eradication of H. pylori-
Public Title	Early phase II Study of TAC-401

Completion Date or Terminated date
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
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	Taiho Pharmaceutical Co., Ltd.
	Address	toiawaseCD1@taiho.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Taiho Pharmaceutical Co., Ltd.
	Address	toiawase@taiho.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		108
Study Type		Interventional
Study Design	Study Design	Central registration, multi-center, open-label, randomized parallel-group study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-Subjects who have H. pylori confirmed based on rapid urease test. -Subjects who have no active peptic ulcer.
	Exclusion Criteria	-Subjects who have received H. pylori eradication treatment. -Subjects with pyloric stenosis. -Subjects with upper gastrointestinal tract disease (reflux oesophagitis etc.) to require treatment. -Subjects with current or previous history of gastric acid hypersecretion disorders (Zollinger-Ellison syndrome etc.). - Subjects with current or previous history of allergic reaction. -Subjects who have received gastrectomy or vagotomy.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		H. pylori infection
Intervention(s)		investigational material(s) Generic name etc : TAC-401 INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material : Thirty mg of TAC-401 is administered orally twice a day for 7 days, 90 mg of TAC-401 is administered orally twice a day for 7 days, or 90 mg of TAC-401 is administered orally twice a day for 14 days.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		H. pylori eradication rate Urea breath test
Secondary Outcome		Serum gastrin level. The serum pepsinogen I and II level and pepsinogen I / II ratio. Incidence of adverse event and side effect. Antibacterial activities of clarithromycin, amoxicillin, methronidazole, levofloxacin and TAC -401 against H. pylori. Blood test, Cultural method

Primary Sponsor	Taiho Pharmaceutical Co., Ltd.
Secondary Sponsor

Name of Funding Organization	Taiho Pharmaceutical Co., Ltd.
Name of Research Funding

Name of IRB	National Center for Global Health and Medicine Hospital Institutional Review Board
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-122028
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Oct. 02, 2013	Detail	Changes
7	Oct. 02, 2013	Detail	Changes
6	Aug. 05, 2013	Detail	Changes
5	Aug. 05, 2013	Detail	Changes
4	Dec. 25, 2012	Detail	Changes
3	Dec. 25, 2012	Detail	Changes
2	Dec. 18, 2012	Detail	Changes
1	Dec. 17, 2012	Detail

List of change history