臨床研究等提出・公開システム

Date of registration	Oct. 19, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220896

Scientific Title	Dose finding study of TAK-438 in patients with reflux esophagitis (phase II study)
Public Title

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	Takeda Pharmaceutical Company Limited
	Address	https://www.takeda.co.jp/contact/form/jp/form/
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Takeda Pharmaceutical Company Limited
	Address	https://www.takeda.co.jp/contact/form/jp/form/
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, multicenter, double-blind study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1. Endoscopic diagnosis of grade A to D reflux esophagitis by LA classification at the start of the follow-up period (visit 1), etc.
	Exclusion Criteria	1. Complications that may affect the esophagus, history of esophageal radiotherapy or cryotherapy, or presence of corrosive or physiochemical trauma 2. History of surgery for reflux esophagitis, dilation of esophageal stricture, or surgery of the stomach or duodenum 3. Acute upper gastrointestinal bleeding or active gastric or duodenal ulcer within 30 days prior to the start of the follow-up period, etc.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Reflux esophagitis
Intervention(s)		investigational material(s) Generic name etc : TAK-438 INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational material : Oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	Takeda Pharmaceutical Company Limited
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
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-090928
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 21, 2015	Detail	Changes
7	Dec. 21, 2015	Detail	Changes
6	Feb. 24, 2014	Detail	Changes
5	Feb. 24, 2014	Detail	Changes
4	Jan. 16, 2013	Detail	Changes
3	Jan. 16, 2013	Detail	Changes
2	Oct. 21, 2009	Detail	Changes
1	Oct. 19, 2009	Detail

List of change history