臨床研究等提出・公開システム

Date of registration	Jan. 10, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080221685

Scientific Title	ZO-Y60 Phase III clinical trial
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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Zeria Pharmaceutical Co., Ltd.
	Address	03-5644-7053
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with gasstrointestinal disease. Out-patients who signed a written informed consent. If patient age is under 20 years old, a written informed consent have to be obtained from both participant and his/her parent(s).
	Exclusion Criteria
	Minimum Age	15age old over
	Maximum Age	64age old under
	Gender	Both
Health Condition or Problem Studied		Gastrointestinal disease
Intervention(s)		investigational material(s) Generic name etc : ZO-Y60 INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : 3 capsules / day
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	ZERIA Pharmaceutical Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	Institutional review board of Fukui Sogo Hospital
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-121727
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	April. 02, 2013	Detail	Changes
5	April. 02, 2013	Detail	Changes
4	July. 04, 2012	Detail	Changes
3	July. 04, 2012	Detail	Changes
2	Jan. 10, 2012	Detail	Changes
1	Jan. 10, 2012	Detail

List of change history