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Date of registration	Nov. 09, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223008

Scientific Title	Efficacy and safety trial of AJG533 in patients with chronic constipation (Phase 3 study)
Public Title	Phase 3 study of AJG533 in patients with chronic constipation

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	EA Pharma Co.,Ltd.
	Address	contact_ea@eapharma.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		120
Study Type		Interventional
Study Design	Study Design	Placebo controlled, randomized, double blind, multicenter, parallel group design
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	<Main inclusion criteria> Patients with chronic constipation
	Exclusion Criteria	<Main exclusion criteria> Patients with known or suspected organic constipation Patients with known or suspected symptomatic constipation or drug-induced constipation
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Chronic constipation
Intervention(s)		investigational material(s) Generic name etc : AJG533 INN of investigational material : elobixibat Therapeutic category code : 235 Purgatives and clysters Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : Placebo 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		Frequency of Spontaneous Bowel Movement Change from baseline
Secondary Outcome		Complete Spontaneous Bowel Movement Rate of Patients Experienced the First SBM within 24 Hours/ 48 Hours SBM and CSBM Responder Rate Time to the First SBM Use of Rescue Medication Stool Consistency Measured by Bristol Stool Form Scale

Primary Sponsor	EA Pharma Co.,Ltd.
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-153062
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
14	Dec. 17, 2018	(this page)	Changes
13	Sept. 27, 2018	Detail	Changes
12	Sept. 27, 2018	Detail	Changes
11	Jan. 22, 2018	Detail	Changes
10	Sept. 30, 2016	Detail	Changes
9	Sept. 30, 2016	Detail	Changes
8	June. 23, 2016	Detail	Changes
7	June. 23, 2016	Detail	Changes
6	June. 20, 2016	Detail	Changes
5	June. 16, 2016	Detail	Changes
4	April. 11, 2016	Detail	Changes
3	April. 11, 2016	Detail	Changes
2	Nov. 09, 2015	Detail	Changes
1	Nov. 09, 2015	Detail

List of change history