臨床研究等提出・公開システム

Date of registration	June. 19, 2013
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222120

Scientific Title	DS-7113b phase II study -A DS-7113b potency ratio assessment study in patients with cancer pain.-
Public Title	DS-7113b 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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHISANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	A multicenter, randomized, double-blind, parallel-group study
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-Patients with cancer pain whose pain is controlled by steady dose of an oral morphine during the screening period. -Patients whose frequency of rescue dose during the screening period is within the specified number. -Patients with an ECOG PS of =<3, etc.
	Exclusion Criteria	Patients with symptom(s)/finding(s) falling under the contraindications or relative contraindications stated in the package insert of oral morphine preparations, etc.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Moderate to severe cancer pain
Intervention(s)		investigational material(s) Generic name etc : DS-7113b INN of investigational material : Hydromorphone hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : Either equianalgesic dose of DS-7113b to oral morphine (potency ratio: 1:5 or 1:8) will be orally administered daily in 6 divided doses.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Pain control achievement rates
Secondary Outcome		Efficacy rate at completion of study treatment, efficacy and safety

Primary Sponsor	DAIICHISANKYO 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-132166
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
12	Dec. 17, 2018	(this page)	Changes
11	Mar. 27, 2018	Detail	Changes
10	Mar. 26, 2018	Detail	Changes
9	June. 19, 2015	Detail	Changes
8	June. 19, 2015	Detail	Changes
7	Nov. 11, 2014	Detail	Changes
6	Nov. 11, 2014	Detail	Changes
5	Sept. 12, 2013	Detail	Changes
4	Sept. 12, 2013	Detail	Changes
3	June. 27, 2013	Detail	Changes
2	June. 19, 2013	Detail	Changes
1	June. 19, 2013	Detail

List of change history