臨床研究等提出・公開システム

Date of registration	Oct. 19, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221274

Scientific Title	A Multicenter Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Study in Opioid-Induced Constipation
Public Title	ONO-3849 Phase II Study

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	ONO PHARMACEUTICAL CO.,LTD.
	Address	y.hirata@ono.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address	ki.morimoto@ono.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		200
Study Type		Interventional
Study Design	Study Design	A Multicenter Randomized Double-Blind Parallel-Group Comparison Study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	1.Age 20 years or older. 2.Patient with constipation on a stable opioid regimen.
	Exclusion Criteria	1.Patients with known or suspected gastrointestinal obstruction. 2.Patients with constipation mainly caused by anybowel dysfunction other than opioid-induced one.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Opioid-induced constipation
Intervention(s)		investigational material(s) Generic name etc : ONO-3849 INN of investigational material : Therapeutic category code : 235 Purgatives and clysters Dosage and Administration for Investigational material : Subcutaneous injection control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Subcutaneous injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Laxation response rate within 4 hours of study drug treatment without rescue laxatives.
Secondary Outcome		Laxation response rate within 24 hours of study drug treatment without rescue laxatives, and so on.

Primary Sponsor	ONO PHARMACEUTICAL 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-101311
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Feb. 29, 2012	Detail	Changes
9	Feb. 29, 2012	Detail	Changes
8	Dec. 28, 2011	Detail	Changes
7	June. 29, 2011	Detail	Changes
6	June. 29, 2011	Detail	Changes
5	April. 21, 2011	Detail	Changes
4	Nov. 05, 2010	Detail	Changes
3	Nov. 05, 2010	Detail	Changes
2	Oct. 19, 2010	Detail	Changes
1	Oct. 19, 2010	Detail

List of change history